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

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00084942
First received: June 10, 2004
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Drug: capecitabine
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: October 2002
Study Completion Date: November 2006
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084942

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

Additional Information:
No publications provided

Responsible Party: Miland Javle, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00084942     History of Changes
Other Study ID Numbers: CDR0000367107, RPCI-RPC-0205
Study First Received: June 10, 2004
Last Updated: January 11, 2012
Health Authority: United States: Food and Drug Administration

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
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014