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

Sponsor

Swiss Group for Clinical Cancer Research (Other)

Overall Status

Completed

CT.gov ID

NCT00073905

Collaborator

(none)

Enrollment

Location

Arm

69.1

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

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 :

Apr 1, 2003

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Arm A

Capecitabine plus Gemcitabine

Drug: capecitabine plus gemcitabine

capecitabine plus gemcitabine

Outcome Measures

Primary Outcome Measures

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

Clinical benefit response alone as measured after 3 courses [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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