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Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

This study has been completed.
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Eli Lilly and Company
Information provided by:
Dana-Farber Cancer Institute Identifier:
First received: July 25, 2005
Last updated: December 20, 2007
Last verified: December 2007
In the United States, the incidence of biliary tract cancer and gallbladder cancer has been estimated to be 6,000-8,000 patients per year. Currently, there is no standard therapy for these tumors once the disease has spread and is inoperable. Recent small studies with gemcitabine have shown a positive response rate. The investigators plan to test the combination of gemcitabine with cisplatin for biliary tract and gallbladder cancers.

Condition Intervention Phase
Gallbladder Cancer Biliary Tract Cancer Drug: Gemcitabine Drug: Cisplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the response rate of the combination gemcitabine and cisplatin in patients with advanced biliary tract and gallbladder cancers

Secondary Outcome Measures:
  • To determine the overall survival rate, progression-free survival rate, time to progression and duration of response
  • To determine the toxicity of gemcitabine and cisplatin
  • To assess the biomarker CA 19-9 response to the regimen and to correlate the CA 19-9 response with radiologic response and survival

Estimated Enrollment: 30
Study Start Date: July 2002
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:
Gemcitabine and cisplatin will be administered weekly for two weeks (on day 1 and day 8) followed by a one week rest period (1 cycle is 3 weeks). On day one and eight of each cycle the patient will have a physical exam and blood work. During the first two cycles, additional blood work will be drawn on day 15 as well. Reassessment of the tumor will be performed at 6 weeks, 12 weeks, and every 9 weeks thereafter. Patients will remain on treatment until further evidence of disease progression or unacceptable side effects occur.

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

Inclusion Criteria:

  • Histologically-confirmed, locally unresectable or metastatic biliary tract (bile ducts, hepatic duct, cystic duct, common bile duct, ampulla of Vater) or gallbladder adenocarcinoma. Patients must have at least one measurable lesion greater than 1 cm, by Response Evaluation Criteria in Solid Tumors (RECIST) criteria outside of prior radiation field.
  • Zero to one prior chemotherapy for biliary tract or gallbladder cancer. Prior chemoembolization to the liver allowed as long as measurable disease is outside of chemoembolization area and other baseline characteristics are met. No prior gemcitabine or cisplatin therapy allowed.
  • No chemotherapy within past 3 weeks of initiation of therapy (6 weeks if prior therapy was mitomycin C or nitrosurea)
  • Chronological age > 18 years.
  • ECOG performance status 0-2; life expectancy >12 weeks.
  • Laboratory values: ANC greater than or equal to 1500/mm3; platelets greater than or equal to 100,000/mm3; SGOT and SGPT less than or equal to 3x upper limits of normal (unless liver is involved with tumor, in which case the transaminases must be less than or equal to 5 x upper limits of normal); total bilirubin less than or equal to 2.0 mg/dL.
  • Creatinine less than or equal to 1.8 mg/dL or creatinine clearance greater than or equal to 50 mL/min
  • All patients must sign informed consent.
  • Patients may have prior placement of stents or shunts to relieve obstruction.

Exclusion Criteria:

  • Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Myocardial infarction in the past six months.
  • Major surgery in the past two weeks.
  • Uncontrolled serious medical or psychiatric illness.
  • Women must not be pregnant or lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study.
  • Patients with concurrent malignancy of any site, except for limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with any other malignancy within 5 years of study entry, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00123825

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Eli Lilly and Company
Principal Investigator: Jeffrey A Meyerhardt, MD Dana-Farber Cancer Institute
  More Information Identifier: NCT00123825     History of Changes
Other Study ID Numbers: 02-065
Study First Received: July 25, 2005
Last Updated: December 20, 2007

Keywords provided by Dana-Farber Cancer Institute:
Biliary Tract

Additional relevant MeSH terms:
Gallbladder Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 16, 2017