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

Hospital de Cancer de Barretos - Fundacao Pio XII

Status and phase: Unknown; Phase 2

Conditions: Biliary Cancer

Treatments: Drug: Gemcitabine; Drug: Cisplatin; Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT01859728

GAMBIT201201

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

IP (irinotecan and cisplatin)

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Irinotecan

Drug: Cisplatin

GC (gemcitabine and cisplatin)

Active Comparator group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: Cisplatin