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Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2009
Sponsors and Collaborators: M.D. Anderson Cancer Center
Genentech
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00652119
  Purpose

Primary study goals:

  • To investigate the safety and tolerability of carboplatin and paclitaxel administered IP in combination with IV Avastin
  • To determine if Avastin influences the pharmacokinetics of IP administered chemotherapeutic agents

Secondary study goals:

  • To determine the systemic exposure to paclitaxel and carboplatin during initial and late cycles of IP dosing.
  • To collect overall survival (OS) and progression-free survival (PFS)
  • To determine changes in IP VEGF levels
  • To determine site of first recurrence
  • Information on CA-125 response and clinical response will be descriptive as secondary goals of this study

Exploratory goal:

-To estimate proportion of patients completing entire course of treatment


Condition Intervention
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Drug: Paclitaxel
Drug: Carboplatin
Drug: Avastin

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Carboplatin Paclitaxel Bevacizumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Trial of Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn about the safety and tolerability of paclitaxel and carboplatin when given in combination with Avastin to patients with ovarian, primary peritoneal, or fallopian tube cancer. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: February 2008
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Paclitaxel + Carboplatin + Avastin
Drug: Paclitaxel
Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle.
Drug: Carboplatin
Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle.
Drug: Avastin
Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed epithelial carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.
  2. Stage III or IV disease. Stage IV disease by virtue of pleural effusions is allowed but stage IV disease with visceral metastases e.g. lung, liver or abdominal wall is NOT ELIGIBLE. Please discuss any eligibility concerns directly with the P.I., Dr. Carolyn Krasner.
  3. Patient must have undergone surgical staging and debulking with optimal (less than 1cm) cytoreduction.
  4. No significant intra-abdominal adhesions or other contraindication to IP port placement.
  5. Patients must give written informed consent.
  6. Patient must be age 18 years or older.
  7. Adequate bone marrow function with an ANC greater that 2,500 and Platelets greater than 100,000 cubic millimeters.
  8. No proteinuria or less than +1; if greater, 24-hour urine collection must be performed to document less than or equal to 1gm/24 hours of protein.
  9. ECOG performance status less than or equal to 1.

Exclusion Criteria:

  1. Visible disease on post-operative imaging (recognizing the limitations of postoperative CT scans due to postoperative changes there should be unequivocal CT evidence of residual disease greater than 1cm)
  2. ECOG performance status greater than or equal to 2
  3. Previous chemotherapy for the disease under study
  4. Suboptimal (greater than 1 cm residual disease) cytoreduction
  5. Creatinine greater than 1.5 mg/dL
  6. SGOT greater than 2 x ULN, bilirubin greater than 1.5 x ULN
  7. Colostomy or ileostomy
  8. Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium.)
  9. Known hypersensitivity to E.coli derived products or to any component of Avastin
  10. Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely
  11. History of myocardial infarction within 6 months
  12. History of stroke or transient ischemia attack within 6 months
  13. Inadequately controlled hypertension greater than 140/90 mm Hg on antihypertensive medication(s)
  14. Any prior history of hypertensive crisis or hypertensive encephalopathy
  15. Clinically significant peripheral vascular disease
  16. Significant vascular disease (e.g. aortic aneurysm, aortic dissection)
  17. Unstable angina
  18. New York Heart Association (NYHA) grade II or greater congestive heart failure
  19. Evidence of coagulopathy or bleeding diathesis
  20. Known central nervous system disease or brain metastases
  21. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 28 (first dose of Avastin), anticipation of need for major surgical procedure during the course of the study
  22. Minor surgical procedures such as fine needle aspirations or core biopsies or laparoscopy for IP catheter placement within 7 days prior to cycle 2 day 8
  23. Open wound, ulcer, or bone fracture
  24. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; current signs and symptoms of bowel obstruction; current dependency on IV hydration or TPN
  25. Pregnant (positive pregnancy test) or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652119

Contacts
Contact: Judith Wolf, MD 713-792-7310

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Judith Wolf, MD            
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech
Investigators
Principal Investigator: Judith Wolf, MD U.T.M.D. Anderson Cancer Center
  More Information

The University of Texas M.D.Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Judith Wolf, MD/Associate Professor )
Study ID Numbers: 2007-0223
Study First Received: March 31, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00652119  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Carcinoma of Mullerian Origin
Paclitaxel
Taxol
Carboplatin
Paraplatin®
Avastin
Bevacizumab
Anti-VEGF monoclonal antibody
rhuMAb-VEGF

Study placed in the following topic categories:
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Antibodies, Monoclonal
Genital Diseases, Female
Peritoneal Diseases
Immunoglobulins
Endocrine Gland Neoplasms
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Abdominal Neoplasms
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Antibodies
Digestive System Diseases
Paclitaxel
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Fallopian tube cancer
Endocrinopathy
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009