A Randomized, Multicenter, Phase II Trial of Cisplatin, Irinotecan and Bevacizumab (PCA) vs. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
- Because no one knows which of the study options is best, participants will be
randomized into one of the two study groups: Arm A or Arm B.
- For both Arm A and Arm B, the chemotherapy will be given in an outpatient setting, once
a week for two weeks in a row, with a rest period for the third week. This three week
period of time is called a cycle.
- During week one Arm A (PCA) participants will receive bevacizumab, cisplatin, and
irinotecan. Arm B (TPCA) participants will receive bevacizumab, docetaxel, cisplatin
- During week two, participants will return to the clinic to receive chemotherapy (both
arms will receive the chemotherapy agents and not bevacizumab). Blood tests and vital
signs will also be collected.
- After 2 cycles of chemotherapy, participants will have CT scans done to see how their
tumor is responding to the chemotherapy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate progression-free survival for each regimen (PCA versus TPCA) at 7 months.
Peter C. Enzinger, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|Texas Oncology Research||Dallas, Texas 75251|