Adjuvant Palliative Capecitabine and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Biliary Tract Cancer

Phase 2

Completed

• Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer; Pain
• Interventions: Drug: capecitabine plus gemcitabine

• Registration Number: NCT00073905
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Palliative chemotherapy may improve the quality of life in patients who have locally advanced or metastatic biliary tract cancer and may help them live more comfortably.

PURPOSE: Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine in improving quality of life in patients who have locally advanced or metastatic biliary tract cancer.

Detailed Description

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-12-10
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Primary Completion: 2006-06
• Study Completion: 2009-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-02
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	capecitabine plus gemcitabine	Capecitabine plus Gemcitabine

Primary Outcome Measures

Name	Time	Method
Ability of palliative capecitabine and gemcitabine	3 months	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 Outcome Measures

Name	Time	Method
Clinical benefit response alone as measured after 3 courses	3 months

Trial Locations

Locations (1)

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland