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A Study of ASA404 or Placebo in Combination With Docetaxel in Second-Line Treatment for (Stage IIIb/IV) Non-Small Cell Lung Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Active | 18 and over | CASA404A2302
EUDRACT number: 2008-002309-38, NCT00738387 |
Trial Description
Summary The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer Eligibility Criteria Inclusion Criteria: 1. Histologically confirmed non-small cell carcinoma of the lung of all histologies. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable.) 2. Patients who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible 3. Age ≥ 18 years old 4. WHO Performance Status of 0-2 5. Measurable or non-measurable disease per RECIST criteria (PTS-1) Exclusion Criteria: 1. Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed). 2. Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ. 3. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities. 4. Major surgery ≤ 4 weeks prior to randomization (major surgery is defined by the use of general anesthesia). Minor surgery ≤ 2 weeks prior to randomization. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications. 5. Treatment with first-line chemotherapy regimen ≤ 3 weeks prior to randomization (≤ 6 weeks for mitomycin and nitrosoureas)
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Ph: 862-778-8300 |
Trial Sites
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| U.S.A. |
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| Alabama |
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Huntsville |
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| | | | | | | | Oncology Specialist, P.c. |
| | | Cathy Cutter, R.N. |
Ph: 256-705-4248 |
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Email:
kathyc@ccihsv.com |
| | | Philip McGee, M.D. | Principal Investigator |
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| Alaska |
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Bentonville |
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| | | | Highlands Oncology Group |
| | | Anessa Conway |
Ph: 479-936-9900 |
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Email:
aconway@hogonc.com |
| | | Joseph Thaddeus Beck | Principal Investigator |
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| Arizona |
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Tucson |
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| | | | Arizona Oncology |
| | | Julie Klinker, R.N. |
Ph: 520-269-3821 |
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Email:
julie.klinker@usoncology.com |
| | | Richard Rosenberg, M.D. | Principal Investigator |
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| California |
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Corona |
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| | | | Compassionate Cancer Care Medical Group |
| | | Helen Vu |
Ph: 951-371-2411 |
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Email:
helen.vu@clinicaidusa.com |
| | | Haresh Jhangiani, M.D. | Principal Investigator |
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Fountain Valley |
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| | | Compassionate Cancer Care Medical Group Incorporated - Fountain Valley |
| | | Dean Bosman |
Ph: 714-210-2300 |
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Email:
dean.bosman@clinicaidusa.com |
| | | An Nguyen, M.D. | Principal Investigator |
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Highland |
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| | | Beaver Medical Group, L.P. |
| | | Patricia Ramos, R.N. |
Ph: 909-425-3372 |
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Email:
pramos@epiclp.com |
| | | Emad Ibrahim, M.D. | Principal Investigator |
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Pleasant Hill |
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| | | Bay Area Cancer Research Group, LLC
- Pleasant Hill |
| | | Mary Mulligan |
Ph: 925-932-9700 Ext.102 |
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Email:
mmiligan@bacrg.com |
| | | Robert Robles, M.D. | Principal Investigator |
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Redlands |
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| | | Loma Linda Oncology Medical Group, Inc. |
| | | Pedro A Bernal |
Ph: 909-796-4333 |
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Email:
pbernal.lloma.research@hotmail.com |
| | | Imtiaz Malik, M.D. | Principal Investigator |
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Riverside |
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| | | Compassionate Cancer Care Medical Group |
| | | Corina King |
Ph: 951-276-2760 |
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Email:
corina.king@clinicaidusa.com |
| | | Hima Bindu Lingam, M.D. | Principal Investigator |
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| Colorado |
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Denver |
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| | | | Rocky Mountain Cancer Centers - Denver Midtown |
| | | Silvia Mosher |
Ph: 303-285-5081 |
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Email:
silvia.mosher@usoncology.com |
| | | Robert Jotte, M.D. | Principal Investigator |
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| Florida |
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Miami |
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| | | | Advanced Medical Specialties |
| | | Elizabeth Groh, R.N. |
Ph: 305-728-1882 |
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Email:
elizabethg@ams-ohrc.com |
| | | Paul Robert Kaywin | Principal Investigator |
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New Port Richey |
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| | | Florida Cancer Institute - New Port Richey |
| | | Suzanne Jacobs |
Ph: 727-843-9841 |
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Email:
suzanne.jacobs@usoncology.com |
| | | Gerald J. Robbins | Principal Investigator |
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Ocala |
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| | | Ocala Oncology Center |
| | | Amy Liebmann |
Ph: 352-732-4938 |
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Email:
amy.liebmann@usoncology.com |
| | | Craig Reynolds, M.D. | Principal Investigator |
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Orlando |
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| | | Cancer Centers of Florida, PA |
| | | Lynn Hogue |
Ph: 407-770-6319 |
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Email:
lynn.hogue@usoncology.com |
| | | Carlos Alemany, M.D. | Principal Investigator |
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| Illinois |
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Decatur |
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| | | | Cancer Care Specialists of Central Illinois, SC - Decatur |
| | | Jean Munson, R.N. |
Ph: 217-876-6635 |
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Email:
jeanm@dmhhs.org |
| | | James Wade, M.D. | Principal Investigator |
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Harvey |
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| | | Comprehensive Cancer Program |
| | | Patricia Gowland, R.N. |
Ph: 708-915-6849 |
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Email:
pgowland@ingalls.org |
| | | Mark Kozloff, M.D. | Principal Investigator |
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| Indiana |
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Indianapolis |
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| | | | Central Indiana Cancer Centers - East |
| | | Tiffany Fox |
Ph: 317-964-5621 |
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Email:
tiffany.fox@usoncology.com |
| | | Hillary Wu, M.D. | Principal Investigator |
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Lafayette |
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| | | Horizon Oncology Center |
| | | Ang Riley, R.N. |
Ph: 765-446-5111 |
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Email:
anley@thecaregroup.org |
| | | Wael Harb, M.D. | Principal Investigator |
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| Kansas |
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Wichita |
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| | | | Cancer Center of Texas |
| | | Tracy Hartup, R.N. |
Ph: 316-613-4316 |
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Email:
tracy.hartup@cancercenterofkansas.com |
| | | Shaker R. Dakhil | Principal Investigator |
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| Kentucky |
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Paducah |
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| | | | Western Kentucky Hematology & Oncology |
| | | Barbie Beach |
Ph: 270-441-4343 |
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Email:
bbeach@hcmr.net |
| | | William Skinner, M.D. | Principal Investigator |
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| Missouri |
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Columbia |
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| | | | Missouri Cancer Associates |
| | | Lisa Mision |
Ph: 573-874-7800 |
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Email:
lisa.mision@usoncology.com |
| | | David Michael Schlossman | Principal Investigator |
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St. Louis |
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| | | David C. Pratt Cancer Center at St. John's Mercy |
| | | Anne Fitzgerald |
Ph: 314-251-7883 |
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Email:
anne.fitzgerald@mercy.net |
| | | Bethany Sleckman, M.D. | Principal Investigator |
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| New Hampshire |
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Hooksett |
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| | | | New Hampshire Oncology-Hematology, PA |
| | | Margie White |
Ph: 603-224-2556 |
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Email:
mwhite@nhoh.com |
| | | Douglas Weckstein, M.D. | Principal Investigator |
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| New Mexico |
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Albuquerque |
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| | | | New Mexico Cancer Center |
| | | Annette Fontaine, M.D. | Principal Investigator |
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| New York |
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Lake Success |
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| | | | Arena Oncology Associates, PC |
| | | Colleen Kats |
Ph: 516-466-6611 Ext.553 |
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Email:
kats@arenaonc.com |
| | | Francis Arena, M.D. | Principal Investigator |
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| Ohio |
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Middletown |
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| | | | Signal Point Hematology Oncology Incorporated |
| | | Susan Smith |
Ph: 513-423-0504 |
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Email:
susan.smith@swohio.twcbc.com |
| | | Nandagopal Vrindavanam, M.D. | Principal Investigator |
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| Tennessee |
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Nashville |
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| | | | Sarah Cannon Research Institute |
| | | Lauren Sade |
Ph: 615-329-7247 |
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Email:
lauren.sade@scresearch.net |
| | | David Spigel, M.D. | Principal Investigator |
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| Texas |
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Abilene |
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| | | | Texas Oncology, PA at Texas Cancer Center - South |
| | | Becky Garcia |
Ph: 325-692-0188 |
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Email:
becky.garcia@usoncology.com |
| | | Anton Melnyk, M.D. | Principal Investigator |
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Arlington |
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| | | Texas Oncology - Arlington South |
| | | Robin Rutt, RN, OCN |
Ph: 817-467-6092 |
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Email:
robin.rutt@usoncology.com |
| | | Sanjay Awasthi, M.D. | Principal Investigator |
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Beaumont |
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| | | Mamie McFadden Ward Cancer Ctr, Texas Oncology |
| | | Shelley Allen, RN, OCN |
Ph: 409-899-7180 |
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Email:
shelley.allen@usoncology.com |
| | | Scott Mckenney, M.D. | Principal Investigator |
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Dallas |
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| | | Methodist Charlton Cancer Center |
| | | Nancy Bennet |
Ph: 972-709-2580 |
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Email:
nancy.bennet@usoncology.com |
| | | John Cox, M.D. | Principal Investigator |
| | | Texas Oncology at Presbyterian Hospital |
| | | Kaylene Smith, R.N. |
Ph: 214-346-3508 |
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Email:
kaylene.smith@usoncology.com |
| | | Kristi McIntyre, M.D. | Principal Investigator |
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Denton |
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| | | Texas Oncology, PA at Texas Cancer Center - Denton |
| | | Debra A Vernon, RN, OCN |
Ph: 940-380-7952 |
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Email:
debbi.vernon@usoncology.com |
| | | Sharad Jain, M.D. | Principal Investigator |
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Midland |
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| | | Texas Oncology - Allison Cancer Center |
| | | Mary Williams, RN, OCN |
Ph: 432-687-1949 |
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Email:
mary.williams@usoncology.com |
| | | David Watkins, M.D. | Principal Investigator |
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Paris |
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| | | Paris Regional Cancer Center |
| | | Sue Crumpler, R.N. |
Ph: 903-785-0031 |
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Email:
sue.crumpler@usoncology.com |
| | | Sucharu Prakash, M.D. | Principal Investigator |
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Sherman |
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| | | Texas Oncology, PA at Texas Cancer Center - Sherman |
| | | Michele Roberts, R.N. |
Ph: 903-868-4783 |
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Email:
michele.roberts@usoncology.com |
| | | Tammy Roque, M.D. | Principal Investigator |
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Tyler |
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| | | Tyler Cancer Center |
| | | Linda Dunklin, RN |
Ph: 903-579-9800 |
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Email:
linsa.dunklin@usoncology.com |
| | | Donald Richards, M.D. | Principal Investigator |
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Waco |
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| | | Texas Oncology Cancer Care Center & Research Center |
| | | Theresa Schroeder, RN, OCN |
Ph: 254-399-0741 |
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Email:
theresa.schroeder@usoncology.com |
| | | Carl Chakmakjian, M.D. | Principal Investigator |
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| Washington |
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Edmonds |
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| | | | Puget Sound Cancer Centers - Edmonds |
| | | Colleen Crawford |
Ph: 425-775-1677 |
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Email:
colleen.crawford@usoncology.com |
| | | Richard McGee, M.D. | Principal Investigator |
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Seattle |
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| | | Puget Sound Cancer Centers - Seattle |
| | | Bennett Reyes |
Ph: 206-365-8252 |
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Email:
bennett.reyes@usoncology.com |
| | | Sam Tolman, M.D. | Principal Investigator |
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Spokane |
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| | | Evergreen Hematology and Oncology |
| | | Michelle Osso, CCRP |
Ph: 509-893-5808 |
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Email:
mosso@evergreen4cure.com |
| | | Stephen Anthony, M.D. | Principal Investigator |
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Tacoma |
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| | | MultiCare Regional Cancer Center at Tacoma General Hospital |
| | | Diane Miller, R.N. | |
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Email:
diane.miller@multicare.org |
| | | Daniel Moore, M.D. | Principal Investigator |
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Vancouver |
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| | | Northwest Cancer Specialists at Vancouver Cancer Center |
| | | Amy Moon |
Ph: 360-449-6511 |
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Email:
amy.moon@usoncology.com |
| | | David A. Smith | Principal Investigator |
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| Belgium |
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Bruxelles |
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| | | | Novartis Investigative Site |
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Genk |
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| | | Novartis Investigative Site |
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Gent |
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| | | Novartis Investigative Site |
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Leuven |
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| | | Novartis Investigative Site |
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Liege |
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| | | Novartis Investigative Site |
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Namur |
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| | | Novartis Investigative Site |
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| Canada |
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Greenfield Park |
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| | | | Novartis Investigative Site |
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Laval |
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| | | Novartis Investigative Site |
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Montreal |
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| | | Novartis Investigative Site |
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Trois-Rivieres |
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| | | Novartis Investigative Site |
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| Germany |
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Hamburg |
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| | | | Novartis Investigative Site |
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Koeln |
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| | | Novartis Investigative Site |
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Ulm |
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| | | Novartis Investigative Site |
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| Italy |
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Aviano |
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| | | | Novartis Investigative Site |
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Milano |
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| | | Novartis Investigative Site |
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Sassari |
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| | | Novartis Investigative Site |
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| Spain |
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Mataro |
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| | | | Novartis Investigative Site |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00738387
Information obtained from ClinicalTrials.gov on May 13, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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