Status:
UNKNOWN
GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
Lead Sponsor:
Hospital de Cancer de Barretos - Fundacao Pio XII
Conditions:
Biliary Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01859728
Start Date
January 1 2013
End Date
December 1 2018
Last Update
January 18 2018
Active Locations (1)
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1
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784400