Gemcitabine and Capecitabine in Treating Patients With Advanced and/or Inoperable Cholangiocarcinoma or Carcinoma of the Gallbladder

NCT ID: NCT00084942

Last Updated: 2012-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2006-11-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced and/or inoperable cholangiocarcinoma or carcinoma (cancer) of the gallbladder.

Detailed Description

OBJECTIVES:

Primary

• Determine the response rate in patients with advanced and/or inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine.

Secondary

• Determine time to disease progression and overall survival of patients treated with this regimen.
• Determine quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 3, 6, 9, and 12.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 9-17 patients will be accrued for this study within 1.5 years.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

capecitabine

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cholangiocarcinoma or carcinoma of the gallbladder

• Advanced and/or inoperable disease
• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 2 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin < 3 mg/dL

Renal

• Creatinine ≤ 1.6 mg/dL

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 4 weeks since prior chemotherapy and recovered
• No more than 1 prior chemoembolization OR chemoradiotherapy regimen for locally advanced biliary tract cancer
• No other prior chemotherapy (except adjuvant therapy)

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy
• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Milind Javle, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

John Gibbs, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-RPC-0205

Identifier Type: -

Identifier Source: secondary_id

CDR0000367107

Identifier Type: -

Identifier Source: org_study_id