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Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

Primary Purpose

Gallbladder Cancer, Biliary Tract Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Cancer focused on measuring Gallbladder, Biliary Tract, Cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Outcomes

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

Full Information

First Posted
July 25, 2005
Last Updated
December 20, 2007
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00123825
Brief Title
Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer
Official Title
A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Cancer, Biliary Tract Cancer
Keywords
Gallbladder, Biliary Tract, Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Primary Outcome Measure Information:
Title
To determine the response rate of the combination gemcitabine and cisplatin in patients with advanced biliary tract and gallbladder cancers
Secondary Outcome Measure Information:
Title
To determine the overall survival rate, progression-free survival rate, time to progression and duration of response
Title
To determine the toxicity of gemcitabine and cisplatin
Title
To assess the biomarker CA 19-9 response to the regimen and to correlate the CA 19-9 response with radiologic response and survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Meyerhardt, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

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