Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

Official title:

A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123825
• Other study ID #: 02-065
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2005
• Last updated: December 20, 2007
• Start date: July 2002
• Est. completion date: October 2007

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Gallbladder Cancer
• Gallbladder Neoplasms

Intervention

Drug:
• Gemcitabine

• Cisplatin

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Eli Lilly and Company, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate of the combination gemcitabine and cisplatin in patients with advanced biliary tract and gallbladder cancers
Secondary	To determine the overall survival rate, progression-free survival rate, time to progression and duration of response
Secondary	To determine the toxicity of gemcitabine and cisplatin
Secondary	To assess the biomarker CA 19-9 response to the regimen and to correlate the CA 19-9 response with radiologic response and survival