CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
triapine +1 moredrug
Likely dose
Triapine IV in combination with gemcitabine IVAI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed adenocarcinoma of biliary ducts (unresectable/metastatic), Ampulla of Vater carcinoma, or unresectable/metastatic gallbladder carcinoma
  • ✓Measurable disease
  • ✓No prior chemotherapy
  • ✓Life expectancy >3 months
Key exclusion· 7
  • ✕Known brain metastases
  • ✕History of allergic reactions to triapine or gemcitabine or similar agents
  • ✕Uncontrolled intercurrent illness (infection, congestive heart failure, unstable angina, cardiac arrhythmia)
  • ✕Uncontrolled pulmonary disease or chronic oxygen requirement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00075504
NCT00075504Phase 2Completed
CompareCT.gov

A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder

National Cancer Institute (NCI)·interventional·Posted Jan 12, 2004·Updated Sep 28, 2015

In Brief

A Phase 2 clinical trial evaluating triapine and gemcitabine for Stage II Gallbladder Cancer and 4 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage II Gallbladder Cancer, Stage IIIA Gallbladder Cancer, Stage IIIB Gallbladder Cancer, Stage IVA Gallbladder Cancer, Stage IVB Gallbladder Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 12, 2004
Enrollment StartNov 1, 2003
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 22.5 years ago

Interventions

triapinedrug

Given IV

gemcitabinedrug

Given IV