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NCT00537121 · ClinicalTrials.gov registry record · Phase 1

Vorinostat, Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Upper Gastrointestinal Cancer

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target

NCT00537121: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.

NCT00537121 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00537121, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target

Study Summary

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced upper gastrointestinal cancer.

Interventions

  • DRUG vorinostat
  • DRUG fluorouracil
  • OTHER pharmacological study
  • DRUG leucovorin calcium
  • DRUG irinotecan hydrochloride

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2006-11
Est. Completion 2013-06
Phase Phase 1
Roswell Park Cancer Institute

365 total trials

What the finished NCT00537121 record still lists

NCT00537121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 5 interventions - of which vorinostat is the first listed.

NCT00537121 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00537121 about?

NCT00537121 is a clinical study titled "Vorinostat, Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Upper Gastrointestinal Cancer". RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them fro...

What is the current status of trial NCT00537121?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2006-11. Estimated completion is 2013-06.

What interventions are being tested in trial NCT00537121?

The interventions under investigation include: vorinostat (DRUG), fluorouracil (DRUG), pharmacological study (OTHER), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00537121?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00537121's enrollment target sits among peer trials

23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00537121, the US trial registry maintained by the National Library of Medicine. NCT00537121 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.