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NCT00911820 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 2
Development phase
88
Enrollment target

NCT00911820: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.

NCT00911820 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00911820, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
88 participants
Enrollment target

Study 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.

Primary Outcome

7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more

Interventions

  • DRUG Bevacizumab
  • DRUG Cisplatin
  • DRUG Irinotecan
  • DEVICE Docetaxel

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2009-07
Est. Completion 2013-08
Phase Phase 2
Dana-Farber Cancer Institute

781 total trials

What the finished NCT00911820 record still lists

NCT00911820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).

The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.

NCT00911820 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00911820 about?

NCT00911820 is a clinical study titled "Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer". 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, Irin...

What is the current status of trial NCT00911820?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2009-07. Estimated completion is 2013-08.

What interventions are being tested in trial NCT00911820?

The interventions under investigation include: Bevacizumab (DRUG), Cisplatin (DRUG), Irinotecan (DRUG), Docetaxel (DEVICE).

Who is sponsoring clinical trial NCT00911820?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00911820's enrollment target sits among peer trials

88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00911820, the US trial registry maintained by the National Library of Medicine. NCT00911820 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.