GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Cancer de Barretos - Fundacao Pio XII
• Treatments: Antiemetics; Camptothecin; Cisplatin; Gemcitabine; Irinotecan

Criteria

Inclusion Criteria:

• biopsy-proven gallbladder or biliary tract cancer;

• Recurrent, metastatic or unresectable disease;

• Chemo-naïve.

• Not candidates to curative-intent treatment, such as surgery or radiation-therapy;

• Measurable disease according to RECIST 1.1;

• ECOG 0-2;

• Adequate hematologic and biochemistry tests;

• Creatinine clearance >= 60ml/min.

Exclusion Criteria:

• Known hypersensibility or previous therapy with cisplatin, gemcitabine or irinotecan;

• Chronic immunosuppressive therapy;

• Known CNS metastasis;

• Previous diagnosis of other cancer;

• Chronic or acute active infection, except asymptomatic HIV infection;

• Active bleeding;

• Any severe medical condition;

• Pregnant or lactating women, or with childbearing potential;