Estudo Clínico de Fase II, Randomizado, Avaliando a combinação de Cisplatina e Irinotecano no Tratamento de Primeira Linha do Carcinoma da vesícula Biliar, Vias Biliares Intra ou Extra-hepáticas irressecável ou metastático (ESTUDO GAMBIT) (GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer)
18 Years
N/A
Both
Biliary Cancer
Trial Information
Estudo Clínico de Fase II, Randomizado, Avaliando a combinação de Cisplatina e Irinotecano no Tratamento de Primeira Linha do Carcinoma da vesícula Biliar, Vias Biliares Intra ou Extra-hepáticas irressecável ou metastático (ESTUDO GAMBIT) (GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer)
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;
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate
Outcome Description:
The overall response rate will measure the number of subjects with complete or partial response as best response during the entire treatment, over the total number of subjects, for each arm. The response will be evaluated according to RECIST 1.1.
Outcome Time Frame:
Up to 24 weeks from randomization
Safety Issue:
No
Principal Investigator
Lucas V dos Santos, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Barretos Cancer Hospital
Authority:
Brazil: Comite Nacional de Ética em Pesquisa CONEP
Study ID:
GAMBIT201201
NCT ID:
NCT01859728
Start Date:
January 2013
Completion Date:
July 2015
Related Keywords:
- Biliary Cancer
- biliary cancer
- irinotecan
- cisplatin
- gemcitabine
- Biliary Tract Neoplasms
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