Trial | NCT01859728  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
Study Started
Jan 31
2013
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Jan 18
2018

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.

  • Other names: CPT-11

Drug Cisplatin

Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.

  • Other names: CDDP

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.

  • Other names: CDDP

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.

IP (irinotecan and cisplatin) Experimental

Irinotecan 65mg/m² D1 and D8 q21 days plus Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.

GC (gemcitabine and cisplatin) Active Comparator

Gemcitabine 1000mg/m² D1 and D8 every 21 days plus cisplatin 25mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.

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;
No Results Posted