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Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Eli Lilly and Company
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00123825
First received: July 25, 2005
Last updated: December 20, 2007
Last verified: December 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123825

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Eli Lilly and Company
Investigators
Principal Investigator: Jeffrey A Meyerhardt, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00123825     History of Changes
Other Study ID Numbers: 02-065
Study First Received: July 25, 2005
Last Updated: December 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Gallbladder
Biliary Tract
Cholangiocarcinoma

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Gallbladder Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Gallbladder Diseases
Neoplasms
Neoplasms by Site
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014