Completed

Triapine and Gemcitabine Combination for Biliary Ducts and Gall Bladder Tumors

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What is being tested

triapine

+ gemcitabine

Drug
Who is being recruted

Biliary Tract Diseases+5

+ Biliary Tract Neoplasms

+ Digestive System Diseases

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

This is a phase 2 study focusing on treating cancers of the biliary ducts and gall bladder. It aims to evaluate the effectiveness of a combination treatment using two drugs: Triapine and Gemcitabine. The study is important as it seeks to find new ways to improve treatment for these types of cancers, potentially leading to better patient outcomes and addressing current challenges in their management. During the study, participants receive Triapine through an IV drip over 4 hours, followed by Gemcitabine through an IV infusion over 30 minutes. This treatment is given on days 1, 8, and 15 of each 28-day cycle. The cycle may repeat up to 12 times, depending on how the patient responds to the treatment and if they experience any unacceptable side effects. The study measures the results by assessing the tumor response every eight weeks using a CT scan and specific criteria (RECIST). It looks at how the tumor size changes, whether it decreases or disappears, to understand the effectiveness of the treatment.

Official TitleA Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder
NCT00075504
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Biliary Tract DiseasesBiliary Tract NeoplasmsDigestive System DiseasesDigestive System NeoplasmsGallbladder DiseasesGallbladder NeoplasmsNeoplasmsNeoplasms by Site

Criteria

11 inclusion criteria required to participate
Histologically or cytologically confirmed adenocarcinoma of the biliary ducts that is unresectable and/or metastatic; this can include unresectable or metastatic carcinomas of the Ampulla of Vater. In addition, unresectable or metastatic gall bladder carcinoma will be allowed
Measurable disease
No prior chemotherapy
Life expectancy of greater than 3 months
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9 exclusion criteria prevent from participating
Patients may not be receiving any other investigational agents
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Triapine or gemcitabine
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Montefiore Medical Center

The Bronx, United StatesOpen Montefiore Medical Center in Google Maps
CompletedOne Study Center