deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm 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

Sponsor: Brigham and Women's Hospital

Updated 7 times since 2017 Last updated: Jul 5, 2017 Started: Sep 30, 2006 Primary completion: Nov 30, 2008 Completion: Oct 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00394433, this PHASE2 trial focuses on Esophageal Cancer and Stomach Cancer and remains completed. Sponsored by Brigham and Women's Hospital, it has been updated 7 times since 2006, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Sep 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Massachusetts General Hospital
Data source: Dana-Farber Cancer Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations