Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00073905
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : June 5, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Pain Drug: capecitabine plus gemcitabine Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial
Study Start Date : April 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : January 2009


Arm Intervention/treatment
Active Comparator: Arm A
Capecitabine plus Gemcitabine
Drug: capecitabine plus gemcitabine
capecitabine plus gemcitabine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical benefit response alone as measured after 3 courses [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073905


Locations
Layout table for location information
Switzerland
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Layout table for investigator information
Study Chair: Dieter Koeberle, MD Cantonal Hospital of St. Gallen

Publications of Results:
Layout table for additonal information
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00073905     History of Changes
Other Study ID Numbers: SAKK 44/02
EU-20322
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
unresectable gallbladder cancer
adenocarcinoma of the gallbladder
adenocarcinoma of the extrahepatic bile duct
unresectable extrahepatic bile duct cancer
pain
recurrent gallbladder cancer
recurrent extrahepatic bile duct cancer
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Gallbladder Neoplasms
Biliary Tract Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs