Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors. PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.

Timeline

Start

2005-05

Primary completion

2008-08

Completion

—

Outcome

Met primary endpoint

paper median overall survival was 11.7 months among the 204 patients in the cisplatin-gemcitabine group and 8.1 months among the 206 patients in the gemcitabine group PMID 20375404 ↗

paper hazard ratio, 0.64; 95% confidence interval, 0.52 to 0.80; P<0.001 PMID 20375404 ↗

Publications

• Results Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
• Lamarca A, Ross P, Wasan HS, Hubner RA, McNamara MG, Lopes A, Palmer DH, Valle JW, Bridgewater J. Advanced extrahepatic cholangiocarcinoma and gallbladder cancer: Post-hoc analysis of the ABC-01, -02 and -03 clinical trials. JHEP Rep. 2026 Mar 24;8(7):101833. doi: 10.1016/j.jhepr.2026.101833. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Indications