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

Phase 2

• Conditions: Biliary Cancer
• Interventions: Drug: Irinotecan; Drug: Cisplatin; Drug: Gemcitabine

• Registration Number: NCT01859728
• Lead Sponsor: Hospital de Cancer de Barretos - Fundacao Pio XII

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-22
• Status Verified: 2015-08
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-18
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IP (irinotecan and cisplatin)	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.
GC (gemcitabine and cisplatin)	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.
IP (irinotecan and cisplatin)	Irinotecan	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)	Gemcitabine	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 Measures

Name	Time	Method
Overall Response Rate	Up to 24 weeks from randomization	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	6mo after the last enrolled patient	We will measure the number of subjects without any-cause death. For each patient, OS will be calculated from randomization until death. OS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median OS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at one and two years will be calculated.
Disease Control Rate	Up to 6 weeks from randomization	The disease control rate will measure the number of subjects with complete or partial response, or disease stabilization 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.
Safety	6 mo after the last enrolled patients	Safety and tolerability will be assessed using NCI CTCAE v3. The number of patients in each arm experiencing any grade Adverse Events (for each AE) and Serious AE (SAE) over the total number of subjects will be measured, and the proportion of patients experiencing AE in each arm will be compared using uncorrected chi-sq test. AE will be recorded in baseline and in each visit, and the worst grade AE will be considered. Each AE will be classified in grades 1-2, 3-4 and SAE.
Progression-Free Survival (PFS)	6mo after the last enrolled patient	We will measure the number of subjects without progressive disease (complete response, partial response or stable disease) or any-cause death, whichever came first. For each patient, PFS will be calculated from randomization until progressive disease. Disease progression means radiologic progression per RECIST 1.1 or any-cause death. PFS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median PFS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the PFS rate at one and two years will be calculated.

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, SP, Brazil