Spots Global Cancer Trial Database for Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

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Trial Identification

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 ID: NCT00123825

Conditions

Gallbladder Cancer

Biliary Tract Cancer

Interventions

Gemcitabine

Cisplatin

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.