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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00084942
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : January 12, 2012
Information provided by:
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Drug: capecitabine Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



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


  • 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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
Study Start Date : October 2002
Actual Primary Completion Date : May 2004
Actual Study Completion Date : November 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 2 months


  • 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


  • 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


Biologic therapy

  • Not specified


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00084942

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Milind Javle, MD Roswell Park Cancer Institute
Principal Investigator: John Gibbs, MD Roswell Park Cancer Institute

Responsible Party: Miland Javle, MD, Roswell Park Cancer Institute Identifier: NCT00084942     History of Changes
Other Study ID Numbers: CDR0000367107
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Gallbladder Neoplasms
Bile Duct Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs