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Last Modified: 1/30/2009     First Published: 11/28/2007  
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Phase III Randomized Study of Adjuvant Chemotherapy Comprising Carboplatin and Paclitaxel With Versus Without Bevacizumab and/or Secondary Cytoreduction Surgery in Patients With Platinum-Sensitive Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Carboplatin and Paclitaxel With or Without Bevacizumab After Surgery in Treating Patients with Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


NCI


GOG-0213
GOG-0213, NCT00565851

Special Category: NCI Web site featured trial

Objectives

Primary

  1. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy comprising carboplatin and paclitaxel with or without bevacizumab increases the duration of overall survival of patients with recurrent platinum-sensitive ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
  2. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases the duration of overall survival relative to second-line paclitaxel and carboplatin alone in these patients.

Secondary

  1. To determine if the addition of bevacizumab to the second-line and maintenance phase of treatment increases the duration of progression-free survival relative to second-line paclitaxel and carboplatin alone in these patients.
  2. To prospectively determine the incidence of carboplatin and paclitaxel hypersensitivity in these patients undergoing retreatment with both agents as first recurrence therapy.
  3. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases quality of life (QOL) of patients with recurrent platinum-sensitive ovarian epithelial cancer or primary peritoneal cavity cancer, as measured by the FACT-O trial outcome index and Rand SF-36 physical functioning scale.
  4. To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases QOL relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum-sensitive ovarian epithelial cancer or primary peritoneal cavity cancer.

Entry Criteria

Disease Characteristics:

  • Patients must have histologic diagnosis of ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or fallopian tube carcinoma
    • Recurrent disease


  • The following histologic epithelial cell types* are allowed:
    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner Tumor
    • Adenocarcinoma not otherwise specified

     [Note: *Prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and subsequently developed an unrelated, new invasive ovarian epithelial or primary peritoneal cavity cancer allowed provided the histological criteria for epithelial cell type is met]



  • Patients with synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded, unless all of the following conditions are met:
    • Stage not greater than I-B
    • No more than superficial myometrial invasion
    • No vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions


  • Patients must have had a complete response to front-line platinum-taxane therapy (at least 3 cycles) and a treatment-free interval without clinical evidence of progressive disease lasting at least 6 months
    • Front-line therapy may have included a biologic agent (e.g., bevacizumab) but an interval of at least 6 months must have elapsed after completion of therapy
    • A complete response to front-line chemotherapy must include the following:
      • Negative physical exam
      • Negative pelvic exam
      • Normalization of CA125, if elevated at baseline
      • Negative radiographic assessment of disease
    • Front-line treatment may include maintenance therapy following complete clinical or pathological response provided recurrent disease is not identified earlier than 6 months following completion of all anticancer treatment
    • Patients who have undergone reassessment laparotomy or laparoscopy following primary therapy are eligible provided they demonstrate a pathologic complete response based on the surgical assessment (i.e., all obtained specimens are histologically negative for disease)


  • Clinically evident measurable or nonmeasurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
    • Each lesion must be ≥ 20 mm when measured by conventional techniques, MRI or CT scan, or ≥ 10 mm when measured by spiral CT scan
    • Nonmeasurable disease defined by symptomatic ascites or pleural effusion
    • Patients with clinically evident measurable or nonmeasurable disease must also have any 1 of the following:
      • CA-125 > 2 times upper limit of normal
      • Histologic confirmation of recurrence in the absence of an elevated CA-125 and measurable disease


Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No prior adjuvant chemotherapy for localized breast cancer unless it was completed more than 5 years ago and the patient remains free of recurrent or metastatic disease
  • No more than 1 prior regimen of chemotherapy (maintenance therapy is not considered a second regimen)
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • No prior chemotherapy for any other abdominal or pelvic tumor
  • No major surgical procedure, open biopsy, or dental extractions or other dental surgery/procedure that results in an open wound within the past 28 days
  • No placement of vascular access device or core biopsy within the past 7 days
  • No concurrent immunotherapy or radiotherapy
  • No anticipation of need for major surgical procedure during the course of the study

Patient Characteristics:

Inclusion criteria:

  • GOG performance status of 0, 1, or 2
  • Platelet count ≥ 100,000/mm3
  • Absolute neutrophil count ≥ 1,500/mm3
  • Creatinine ≤ 1.5 mg/dL (133 < mol/L) OR creatinine clearance ≥ 60 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT/AST and alkaline phosphatase ≤ 2.5 times ULN (< 5.0 times ULN in the presence of liver metastasis)
  • Urine protein-to-creatinine ratio < 1.0 mg/dL
  • Signed an approved informed consent and authorization permitting release of personal health information
  • Patients with allergic (i.e., hypersensitivity) reactions to these chemotherapeutic agents are eligible if they were successfully retreated following a desensitization program or protocol

Exclusion criteria:

  • Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation
  • Patients with uncontrolled infection
  • Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
  • Patients with peripheral neuropathy ≥ grade 2
  • Patients with a history of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients of childbearing potential not practicing adequate contraception or patients who are pregnant or nursing
  • Patients with other invasive malignancies, with the exception of nonmelanoma skin cancer, or patients who had (or have) any evidence of the other cancer present within the past 5 years or whose previous cancer treatment contraindicates this protocol therapy
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or a history of stroke within the past 5 years
  • Patients with clinically significant cardiovascular disease including any of the following:
    • Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or 2nd or 3rd degree atrioventricular block)
    • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months
    • New York Heart Association grade II or greater congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Grade II or greater peripheral vascular disease unless (<24 hrs) episodes of ischemia managed non-surgically and without permanent deficit
    • History of cerebrovascular accident within the past 6 months
    • No significant traumatic injury within the past 28 days

Expected Enrollment

660

Outcomes

Primary Outcome(s)

Overall survival

Secondary Outcome(s)

Progression-free survival
Frequency and severity of adverse events

Outline

This is a multicenter study. Patients are assigned to 1 of 2 treatment groups. Patients who are not candidates for surgical cytoreduction (i.e., those for whom complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking) are eligible to receive chemotherapy after randomization. Patients who are eligible for surgery undergo abdominal exploration with cytoreduction and undergo tumor tissue collection and complete a quality of life questionnaire before and after surgery. All patients are then randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1.


  • Arm II: Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1.


Treatment in both arms repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of therapy. Patients with stable disease or partial regression receive a maximum of 6 courses. Patients without measurable lesions as determined by a CT scan prior to initiating study treatment continue therapy for 6 courses or, if CA-125 normalizes, for 2 cycles beyond CA-125 normalization, whichever is greater. Patients in arm II then receive a maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment with bevacizumab alone repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Robert Coleman, MD, Protocol chair
Ph: 713-745-3357; 800-392-1611
Email: rcoleman@mdanderson.org
Scott Eisenkop, MD, FACOG, Protocol co-chair
Ph: 408-378-6131
Deborah Armstrong, MD, Protocol co-chair
Ph: 410-614-2743
Email: darmstro@jhmi.edu
Thomas Herzog, MD, Protocol co-chair
Ph: 212-305-3410
Paul Sabbatini, MD, Protocol co-chair
Ph: 212-639-6423; 800-525-2225

Trial Sites

U.S.A.
California
  Burbank
 Providence Saint Joseph Medical Center - Burbank
 Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank
Ph: 818-847-3220
  Long Beach
 Todd Cancer Institute at Long Beach Memorial Medical Center
 Krishnansu Tewari
Ph: 562-933-0900
  Los Angeles
 Jonsson Comprehensive Cancer Center at UCLA
 Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA
Ph: 888-798-0719
 Kaiser Permanente Medical Center - Los Angeles
 Scott Lentz, MD
Ph: 323-783-4018
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 Clinical Trials Office - Chao Family Comprehensive Cancer Center
Ph: 877-UC-STUDY
 Email: ucstudy@uci.edu
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
Colorado
  Aurora
 Colorado Gynecologic Oncology Group, PC
 Susan Davidson, MD
Ph: 303-315-7897
  Englewood
 Rocky Mountain Gynecologic Oncology
 Kevin Davis, MD
Ph: 303-781-9090
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Clinical Trials Office - Helen and Harry Gray Cancer Center
Ph: 860-545-5363
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Clinical Trials Office - George Bray Cancer Center
Ph: 860-224-5660
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
District of Columbia
  Washington
 Washington Cancer Institute at Washington Hospital Center
 Clinical Trials Office - Washington Cancer Institute
Ph: 202-877-8839
Florida
  Fort Myers
 Florida Gynecologic Oncology - Fort Myers
 Edward Grendys, MD
Ph: 239-992-0077
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service
Ph: 866-574-5124
 Email: Sylvester@emergingmed.com
Georgia
  Macon
 Central Georgia Gynecologic Oncology
 Gary Eddy, MD
Ph: 476-633-6090
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute
Ph: 912-350-8568
Illinois
  Arlington Heights
 Northwest Community Hospital
 Josh Tunca, MD
Ph: 847-358-2009
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3019
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Ph: 312-695-1301
 Email: cancer@northwestern.edu
 Rush University Medical Center
 Clinical Trials Office - Rush University Medical Center
Ph: 312-942-5498
 Email: clinical_trials@rush.edu
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
  Hinsdale
 Hinsdale Hematology Oncology Associates
 Sudarshan Sharma, MD
Ph: 630-856-6757
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3019
  Palatine
 Chicago Gynecologic Oncology, SC
 Josh Tunca, MD
Ph: 847-358-2009
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart General Hospital
 Michael Rodriguez
Ph: 574-294-2621
  Indianapolis
 St. Vincent Indianapolis Hospital
 Clinical Trials Office - St. Vincent Indianapolis Hospital
Ph: 317-338-2194
  Kokomo
 Howard Community Hospital
 Michael Rodriguez
Ph: 765-453-8571
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Michael Rodriguez
Ph: 219-326-2683
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3019
  Munster
 Community Hospital
 Erwin Robin, MD
Ph: 219-836-2860
  South Bend
 CCOP - Northern Indiana CR Consortium
 Michael Rodriguez
Ph: 574-647-7370
800-284-7370
 Memorial Hospital of South Bend
 Clinical Trials Office - Memorial Hospital of South Bend
Ph: 800-284-7370
 Saint Joseph Regional Medical Center
 Michael Rodriguez
Ph: 574-237-7111
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Cancer Information Service
Ph: 800-237-1225
Louisiana
  Baton Rouge
 Woman's Hospital
 Giles Fort, MD
Ph: 225-358-1071
Maryland
  Baltimore
 Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
 Clinical Trials Office - Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Ph: 443-777-7364
  Elkton MD
 Union Hospital Cancer Program at Union Hospital
 Mark Borowsky
Ph: 410-398-4000
Massachusetts
  Worcester
 UMASS Memorial Cancer Center - University Campus
 Susan Zweizig, MD
Ph: 508-334-1160
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Angela Kueck
Ph: 877-590-5995
 Saint Joseph Mercy Cancer Center
 Angela Kueck
Ph: 734-712-5658
888-474-4673
 University of Michigan Comprehensive Cancer Center
 Clinical Trials Office - University of Michigan Comprehensive Cancer Center
Ph: 800-865-1125
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Marianne Lange, MD
Ph: 616-977-6243
  Big Rapids
 Mecosta County Medical Center
 Marianne Lange, MD
Ph: 616-977-6243
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Jonathan Tammela
Ph: 800-432-6049
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Marianne Lange, MD
Ph: 616-977-6243
 CCOP - Grand Rapids
 Marianne Lange, MD
Ph: 616-977-6243
 Lacks Cancer Center at Saint Mary's Health Care
 Marianne Lange, MD
Ph: 616-977-6243
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Holland
 Holland Community Hospital
 Marianne Lange, MD
Ph: 616-977-6243
  Iron Mountain
 Dickinson County Healthcare System
 Jonathan Tammela
Ph: 906-774-1313
  Jackson
 Foote Memorial Hospital
 Angela Kueck
Ph: 517-788-4800
  Lansing
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Angela Kueck
Ph: 734-464-4800
  Muskegon
 Hackley Hospital
 Marianne Lange, MD
Ph: 616-977-6243
  Petoskey
 Northern Michigan Hospital
 Marianne Lange, MD
Ph: 616-977-6243
  Pontiac
 St. Joseph Mercy Oakland
 Angela Kueck
Ph: 248-858-3612
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Angela Kueck
Ph: 810-985-1484
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus
Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Michael Rodriguez
Ph: 269-983-8698
800-303-8399
  Traverse City
 Munson Medical Center
 Marianne Lange, MD
Ph: 616-977-6243
  Warren
 St. John Macomb Hospital
 Angela Kueck
Ph: 586-573-5757
888-593-2237
  Wyoming
 Metro Health Hospital
 Marianne Lange, MD
Ph: 616-977-6243
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Duluth
 St. Luke's Hospital Cancer Care Center
 Tanya Repka, MD, FACP
Ph: 218-726-3081
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Mississippi
  Jackson
 St. Dominic Cancer Center
 Donald Seago
Ph: 601-200-3070
 University of Mississippi Cancer Clinic
 James Thigpen, MD
Ph: 601-984-5590
Missouri
  Saint Louis
 Arch Medical Services, Incorporated at Center for Cancer Care and Research
 Alan Lyss, MD
Ph: 314-996-5514
 Missouri Baptist Cancer Center
 Alan Lyss, MD
Ph: 314-996-5514
 Saint Louis University Cancer Center
 Clinical Trials Office - Saint Louis University Cancer Center
Ph: 314-977-4440
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Mutch, MD
Ph: 314-362-3181
  Springfield
 CCOP - Cancer Research for the Ozarks
 Robert Carolla
Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Robert Carolla
Ph: 417-269-5257
 St. John's Regional Health Center
 Robert Carolla
Ph: 417-820-2000
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Peter Morris, MD
Ph: 402-354-5250
Nevada
  Las Vegas
 Women's Cancer Center - Lake Mead
 Nick Spirtos, MD
Ph: 408-866-3843
New Jersey
  Marlton
 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
 Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Ph: 888-847-8823
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Daniel Tobias
Ph: 973-971-6100
800-247-9580
  Neptune
 Jersey Shore Cancer Center at Jersey Shore University Medical Center
 Henry Sprance, MD, PhD
Ph: 732-776-4128
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
  Summit
 Overlook Hospital
 Daniel Tobias
Ph: 908-522-2000
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Howard Saul, DO
Ph: 856-673-0015
New Mexico
  Albuquerque
 Southwest Gynecologic Oncology Associates, Incorporated
 Carolyn Muller, MD
Ph: 505-272-0185
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Albany
 Women's Cancer Care Associates
 Daniel Kredentser, MD
Ph: 518-458-1390
  Brooklyn
 SUNY Downstate Medical Center
 Ovadia Abulafia, MD
Ph: 718-270-2152
  Lake Success
 Long Island Radiation Therapy - Lake Success
 Veena John
Ph: 516-394 - 8100
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital
Ph: 516-734-8900
  New York
 Memorial Sloan-Kettering Cancer Center
 Mario Leitao, Jr.
Ph: 212-639-8895
800-525-2225
 Mount Sinai Medical Center
 Jamal Rahaman
Ph: 212-241-6500
  Stony Brook
 Stony Brook University Cancer Center
 Clinical Trials Office - Stony Brook University Cancer Center
Ph: 800-862-2215
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
North Carolina
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 Janak Choksi, MD
Ph: 336-538-7737
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Clinical Trials Office - Lineberger Comprehensive Cancer Center
Ph: 877-668-0683; 919-966-4432
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital
Ph: 704-384-5369
  Durham
 Duke Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
Ph: 888-275-3853
  Greenville
 Gynecologic Oncology Network
 Howard Homesley, MD
Ph: 252-756-5388
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Eric Jenison, MD
Ph: 330-344-6041
  Canton
 Aultman Cancer Center at Aultman Hospital
 Clinical Trials Office - Aultman Cancer Center at Aultman Hospital
Ph: 330-363-6891
  Cleveland
 Case Comprehensive Cancer Center
 Clinical Trials Office - Case Comprehensive Cancer Center
Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital
Ph: 216-476-9362
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Peter Rose, MD
Ph: 216-444-1712
  Columbus
 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
 Clinical Trials Office - OSU Comprehensive Cancer Center
Ph: 614-293-4976
 Email: osu@emergingmed.com
 Mount Carmel Health - West Hospital
 Luis Vaccarello, MD
Ph: 614-383-6000
 Riverside Methodist Hospital Cancer Care
 Clinical Trials Office - Riverside Methodist Hospital Cancer Care
Ph: 614-566-4475
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Steven Waggoner, MD
Ph: 216-844-5011
  Mentor
 Lake/University Ireland Cancer Center
 Steven Waggoner, MD
Ph: 216-844-5011
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert Mannel, MD
Ph: 405-271-8787
  Tulsa
 Cancer Care Associates - Saint Francis Campus
 Robert Mannel, MD
Ph: 405-271-8787
Oregon
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Ph: 503-413-1742
 Northwest Cancer Specialists at Rose Quarter Cancer Center
 William Winter, III
Ph: 503-228-6509
 Oregon Health and Science University Cancer Institute
 Clinical Trials Office - Oregon Health and Science University Cancer Institute
Ph: 503-494-1080
 Email: trials@ohsu.edu
 Williamette Gynecologic Oncology PC
 Paul Kucera, MD
Ph: 503-561-5294
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital
Ph: 215-481-2402
  Bryn Mawr
 Bryn Mawr Hospital
 Clinical Trials Office - Bryn Mawr Hospital
Ph: 610-645-2680
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Clinical Trials Office - Cancer Center of Paoli Memorial Hospital
Ph: 610-648-1637
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
 Fox Chase Cancer Center CCOP Research Base
 Clinical Trials Office - Fox Chase Cancer Center CCOP Research Base
Ph: 215-728-2983
 Joan Karnell Cancer Center at Pennsylvania Hospital
 Bernard Mason, MD
Ph: 215-829-6088
  Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Clinical Trials Office - McGlinn Family Regional Cancer Center
Ph: 610-988-9323
  Wynnewood
 CCOP - Main Line Health
 Paul Gilman, MD
Ph: 610-645-2000
 Lankenau Cancer Center at Lankenau Hospital
 Paul Gilman, MD
Ph: 610-645-2000
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Clinical Trials Office - Women and Infants Hospital of Rhode Island
Ph: 401-274-1122
South Dakota
  Rapid City
 Black Hills Obstetrics & Gynecology LLP
 Helen Frederickson, MD
Ph: 605-343-9224
Tennessee
  Johnson City
 East Tennessee State University Cancer Center at Johnson City Medical Center
 Clinical Trials Office - East Tennessee State University Cancer Center at Johnson City Medical Center
Ph: 423-433-6210
Texas
  Amarillo
 Harrington Cancer Center
 Clinical Trials Officec - Harrington Cancer Center
Ph: 806-359-4673
 Email: ryokubaitis@harringtoncc.org
  Dallas
 Parkland Memorial Hospital
 David Miller, MD
Ph: 214-648-3026
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Ph: 866-460-4673; 214-648-7097
  Galveston
 University of Texas Medical Branch
 Clinical Trials Office - University of Texas Medical Branch
Ph: 409-772-1950
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245
 Methodist Hospital
 Tri Dinh
Ph: 713-441-1010
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Clinical Trials Office - Huntsman Cancer Institute at University of Utah
Ph: 801-581-4477
 Email: clinical.trials@hci.utah.edu
Vermont
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Susan Modesitt
Ph: 434-924-9333
800-223-9173
  Roanoke
 Carilion Gynecologic Oncology Associates
 Dennis Scribner, MD
Ph: 540-345-8574
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Jonathan Tammela
Ph: 920-884-3135
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Jonathan Tammela
Ph: 920-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Jonathan Tammela
Ph: 920-498-4200
 St. Vincent Hospital Regional Cancer Center
 Clinical Trials Office - St. Vincent Hospital Regional Cancer Center
Ph: 920-433-8889
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Clinical Trials Office - Gundersen Lutheran Cancer Center
Ph: 608-775-2385
 Email: cancerctr@gundluth.org
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Ph: 608-262-5223
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Clinical Trials Office - Froedtert Hospital
Ph: 414-805-3666
 Medical College of Wisconsin Cancer Center
 Clinical Trials Office - Medical College of Wisconsin Cancer Center
Ph: 414-805-4380
 Medical Consultants, Limited
 Peter Johnson, MD(Contact information may not be current)
Ph: 262-549-6662
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Clinical Trials Office - Vince Lombardi Cancer Clinic
Ph: 414-649-5717
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Jonathan Tammela
Ph: 920-846-3444
800-432-6049
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Clinical Trials Office - Vince Lombardi Cancer Clinic - Sheboygan
Ph: 414-649-7200
  Slinger
 Vince Lombard Cancer Clinic at Aurora Health Center - Slinger
 Peter Johnson, MD(Contact information may not be current)
Ph: 262-549-6662
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Jonathan Tammela
Ph: 800-432-6049
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Peter Johnson, MD(Contact information may not be current)
Ph: 262-549-6662

Related Information

Featured trial article

Registry Information
Official Title A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel alone or in Combination with Bevacizumab (NSC #704865, IND #7921) followed by Bevacizumab and Secondary Cytoreduction Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer
Trial Start Date 2007-12-07
Trial Completion Date 2009-12-17 (estimated)
Registered in ClinicalTrials.gov NCT00565851
Date Submitted to PDQ 2007-10-29
Information Last Verified 2009-01-30
NCI Grant/Contract Number CA27469

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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