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


Phase 2
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer

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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 InstituteBuffalo, New York  14263