Completed

Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial

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What is being tested

capecitabine plus gemcitabine

Drug
Who is being recruted

Adenocarcinoma
+14

+ Bile Duct Diseases
+ Bile Duct Neoplasms
From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 2
Interventional
Study Start: April 2003
See protocol details

Summary

Principal SponsorSwiss Group for Clinical Cancer Research
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as measured by the clinical benefit response in patients with locally advanced or metastatic biliary tract cancer. Secondary * Determine the clinical benefit response in patients treated with this regimen. * Determine the time to and duration of clinical benefit response in patients treated with this regimen. * Determine the objective response and time to progression in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the adverse events in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 (28 total doses). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive additional courses at the discretion of the investigator. Quality of life is assessed at baseline, weekly during weeks 2-9 (courses 1-3), and then before each administration of gemcitabine. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 19-44 patients will be accrued for this study within 3 years.

Official TitleCapecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial 
NCT00073905
Principal SponsorSwiss Group for Clinical Cancer Research
Last updated: January 18, 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
44 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

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.
From 18 to 80 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
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Cholangiocarcinoma
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed biliary tract cancer * Locally advanced, unresectable, or metastatic disease * Metastatic adenocarcinoma with clinical documentation of gallbladder or bile tree involvement with no evidence of another primary adenocarcinoma allowed * Measurable or nonmeasurable disease * Treatable biliary duct obstruction must be relieved by either internal endoscopic drainage/stenting or palliative bypass surgery before study entry * Symptomatic biliary tract cancer and has at least 1 of the following: * Karnofsky 60-80% * Baseline analgesic consumption at least 10 mg of morphine equivalents per day * Baseline pain intensity score of at least 20 mm out of a possible 100 mm * No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * See Disease Characteristics * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic * Bilirubin no greater than 4 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * AST and ALT no greater than 5 times ULN Renal * Creatinine clearance greater than 50 mL/min Cardiovascular * No uncontrolled cardiovascular disease Gastrointestinal * Able to ingest oral medication * No malabsorption syndrome * No intractable nausea and/or vomiting * No partial small bowel obstruction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after study participation * No active autoimmune disease * No uncontrolled diabetes * No known hypersensitivity to fluorouracil * No known dihydropyrimidine dehydrogenase deficiency * No definitive contraindication to corticosteroids * No prior significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) that would preclude understanding or providing informed consent * No prior severe reaction to fluoropyrimidine therapy * No psychiatric disorder, cognitive dysfunction, or language problem that would preclude filling out the quality of life questionnaire or patient diary * No other serious underlying medical condition that would preclude study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy * No prior immunotherapy Chemotherapy * No prior chemotherapy for advanced/metastatic disease * No prior palliative chemotherapy Endocrine therapy * No concurrent megestrol Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy * Treatment of a single painful lesion allowed Surgery * See Disease Characteristics * Prior Whipple procedure allowed * Prior duodenal bypass allowed * No concurrent endoscopic or external biliary drainage as a consequence of progressive malignant bile duct obstruction * Drainage as a consequence of nonmalignant bile duct obstruction allowed Other * More than 30 days since prior treatment within a clinical study * No other concurrent anticancer drugs * No other concurrent investigational drugs * No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)


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
Active Comparator
Capecitabine plus Gemcitabine

capecitabine plus gemcitabine
Study Objectives
Primary Objectives

Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as measured by the clinical benefit response.
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
Kantonsspital - St. GallenSt. Gallen, SwitzerlandSee the location

CompletedOne Study Center
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