Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT00394433
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2006-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: