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

June 2, 2012 updated by: Swiss Group for Clinical Cancer Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Capecitabine plus Gemcitabine
Drug: capecitabine plus gemcitabine
capecitabine plus gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of palliative capecitabine and gemcitabine
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical benefit response alone as measured after 3 courses
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 10, 2003

First Submitted That Met QC Criteria

December 10, 2003

First Posted (Estimate)

December 11, 2003

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 2, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 44/02
  • EU-20322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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