A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide With or Without Obatoclax Administered Every 3 Weeks to Patients With Extensive- Stage Small Cell Lung Cancer (ES-SCLC)
In the Phase I portion, both 3 hour and 24 hour infusions of obatoclax with carboplatin
and etoposide every 3 weeks will be evaluated at different doses. In the Phase II portion, 3
hour infusions of obatoclax with or without carboplatin and etoposide every three weeks will
be evaluated for response rates.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the recommended Phase II dose of obatoclax administered as a 3-hour or 24-hour infusion for 3 consecutive days in Phase I, and response rate in Phase II.
6 months
Yes
Jean Viallet, MD
Study Director
Gemin X Pharmaceuticals
United States: Food and Drug Administration
GEM017
NCT00682981
May 2008
November 2011
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Tyler Cancer Center | Tyler, Texas 75702 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
University of Chicago | Chicago, Illinois 60637 |
Florida Cancer Institute | New Port Richey, Florida 34652 |
The West Clinic | Memphis, Tennessee 38120 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Mid Ohio Oncology/Hematology, Inc. | Columbus, Ohio 43213 |
University of Pennsylvania Abramson Cancer Center | Philadelphia, Pennsylvania 19104 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Northwest Georgia Oncology Centers | Marietta, Georgia 30060 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Kalamazoo Hematology and Oncology | Kalamazoo, Michigan 49048 |
McLeod Cancer & Blood Center | Johnson City, Tennessee 37604 |
Northwest Alabama Cancer Center | Muscle Shoals, Alabama 35661 |
UT Southwestern Medical Center at Dallas | Dallas, Texas 75390 |
Mayo Clinic-Arizona | Scottsdale, Arizona 85259 |
City of Hope and Beckman Research Institute | Duarte, California 91010 |
University of California-San Diego Moores Cancer Center | LaJolla, California 92093-0987 |
Georgetown University Hospital-Lombardi Comprehensive Cancer Center | Washington, District of Columbia 20007 |
University of Miami-Sylvester Cancer Center | Miami, Florida 33136 |
Iowa Blood and Cancer Center, PLC | Cedar Rapids, Iowa 52402 |
James Brown Cancer Center | Louisville, Kentucky 40202 |
Cancer Care Associates-Oklahoma City | Oklahoma City, Oklahoma 73112 |
Cancer Care Associates-Tulsa | Tulsa, Oklahoma 74136 |
Greater Philadelphia Cancer and Hematology Specialists | Philadelphia, Pennsylvania 19114 |
Baylor | Dallas, Texas 75246 |