NCT01859728

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

GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Hospital de Cancer de Barretos - Fundacao Pio XII · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Biliary Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 65mg/m² D1 and D8 q21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.
DRUG	Cisplatin	Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.
DRUG	Cisplatin	Cisplatin 25mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity. , with standard hydration and antiemetics. Given in association with standard hydration and anti-emetics.
DRUG	Gemcitabine	Gemcitabine 1000mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2013-05-22
• Last updated: 2018-01-18

Locations

1 site across 1 country: Brazil