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NCT00075504 · ClinicalTrials.gov registry record · Phase 2

Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
33
Enrollment target

NCT00075504: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00075504 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00075504, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
33 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells by making them more sensitive to the drug.

Primary Outcome

Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.

Interventions

  • DRUG gemcitabine
  • DRUG triapine

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2003-11
Est. Completion 2009-01
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00075504 record still lists

NCT00075504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 2 interventions - of which gemcitabine is the first listed.

NCT00075504 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00075504 about?

NCT00075504 is a clinical study titled "Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer". This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop g...

What is the current status of trial NCT00075504?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2003-11. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00075504?

The interventions under investigation include: gemcitabine (DRUG), triapine (DRUG).

Who is sponsoring clinical trial NCT00075504?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00075504's enrollment target sits among peer trials

33 1553rd of 2000 higher than 438 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 NCT00075504, the US trial registry maintained by the National Library of Medicine. NCT00075504 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.