Completed

A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma

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What is being tested

Data Collection

Who is being recruted

Adenocarcinoma
+12

+ Bile Duct Diseases
+ Bile Duct Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2002
See protocol details

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2002Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the response rate in patients with advanced and/or inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine. Secondary * Determine time to disease progression and overall survival of patients treated with this regimen. * Determine quality of life of patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 3, 6, 9, and 12. Patients are followed monthly. PROJECTED ACCRUAL: A total of 9-17 patients will be accrued for this study within 1.5 years.

Official TitleA Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma 
NCT00084942
Principal SponsorRoswell Park Cancer Institute
Last updated: January 13, 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.
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.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Adenocarcinoma
Bile Duct Diseases
Bile Duct Neoplasms
Biliary Tract Diseases
Biliary Tract Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Gallbladder Diseases
Gallbladder Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Cholangiocarcinoma
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed cholangiocarcinoma or carcinoma of the gallbladder * Advanced and/or inoperable disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 2 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 3 mg/dL Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy and recovered * No more than 1 prior chemoembolization OR chemoradiotherapy regimen for locally advanced biliary tract cancer * No other prior chemotherapy (except adjuvant therapy) Endocrine therapy * Not specified Radiotherapy * See Chemotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer agents or therapies



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
Roswell Park Cancer InstituteBuffalo, United StatesSee the location

CompletedOne Study Center
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