A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
18 Years
N/A
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Trial Information
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Milind Javle, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000367107
NCT ID:
NCT00084942
Start Date:
October 2002
Completion Date:
November 2006
Related Keywords:
- Extrahepatic Bile Duct Cancer
- Gallbladder Cancer
- cholangiocarcinoma of the gallbladder
- recurrent gallbladder cancer
- unresectable gallbladder cancer
- cholangiocarcinoma of the extrahepatic bile duct
- recurrent extrahepatic bile duct cancer
- unresectable extrahepatic bile duct cancer
- Gallbladder Neoplasms
- Bile Duct Neoplasms
- Cholangiocarcinoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
