NCT00394433

Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.

Detailed description

OBJECTIVES: Primary To determine the 10-month progression-free survival rate for the combination of TPC and Bevacizumab in patients with metastatic esophageal or gastric cancer Secondary * To determine the response rate (RECIST) and median duration of response * To determine overall survival * To determine toxicity Exploratory * To explore if 7/7 and 7/6 UGT1A1 polymorphisms correlate with grade III/IV irinotecan-related diarrhea and neutropenia when irinotecan is given at relatively low dose to patients with esophageal and gastric cancer * To correlate expression of tumoral and serum VEGF with response and survival * To correlate TGF alpha levels and tumor microvessel density with clinical activity * To examine circulating endothelial cells (CECs) as surrogate markers of antitumor activity of bevacizumab DESIGN This trial will use a single stage design to differentiate a \>/= 50% rate of 10-month progression-free survival from a \</= 30% rate. The proposed regimen would be promising if at least 15 of 35 patients were alive and progression-free at 10 months.

Conditions

• Esophageal Cancer
• Stomach Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab
DRUG	Docetaxel
DRUG	Cisplatin
DRUG	Irinotecan

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-11-01
• Completion: 2016-10-01
• First posted: 2006-11-01
• Last updated: 2017-08-01
• Results posted: 2017-01-16

Locations

3 sites across 1 country: United States