Overview

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;