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

Sponsor
Hospital de Cancer de Barretos - Fundacao Pio XII
Study ID
NCT01859728
Phase
PHASE2
Status
Unknown

Conditions

  • Biliary Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 31, 2013
Status verified
Aug 2015
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IP (irinotecan and cisplatin)
    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.
  • Active Comparator: GC (gemcitabine and cisplatin)
    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.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 24 weeks from randomization ]

Central Contacts

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