Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Summary
There is no clear standard of care for metastatic stomach or esophageal cancer in the United States. The purpose of this research study is to determine the differences between two regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body). Bevacizumab is believed to stop the formation of new blood vessels that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been studied in patients with esophageal and gastric cancer, and we are trying to determine if one regimen will keep your cancer from growing and improve how long you can live.
Timeline
- Start
- 2009-07
- Primary completion
- 2012-04
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 65 mg/m2 | Intravenous |
| Comparator | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |