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Clinical Trials/NCT00084942
NCT00084942CompletedPhase 2

A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma

Roswell Park Cancer Institute2 sites in 1 countryStarted: October 1, 2002Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Locations
2

Study Overview

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • 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
  • Bilirubin < 3 mg/dL
  • Creatinine ≤ 1.6 mg/dL
  • Cardiovascular
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • 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
  • Not specified
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other

Study Sites (2)

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