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

Biliary Cancer Clinical Trial

— GAMBIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01859728
• Other study ID #: GAMBIT201201
• Status: Recruiting
• Phase: Phase 2
• First received: May 14, 2013
• Last updated: January 17, 2018
• Start date: January 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: Barretos Cancer Hospital
• Contact: Lucas V dos Santos, MD
• Phone: +5517-81544670
• Email: lucasvsantos[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Biliary Cancer
• Biliary Tract Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Cancer de Barretos - Fundacao Pio XII

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarker evaluation	The following biomarkers will be tested by immunohistochemistry: human equilibrative nucleoside transporter (hENT), X-ray repair cross-complementing protein 1 (XRCC1), Excision repair cross-complementing rodent repair deficiency, complementation group 1 (ERCC1) e mLH1. Then we will correlate them with efficacy end-points using non-parametric test.	Baseline
Primary	Overall Response Rate	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.	Up to 24 weeks from randomization
Secondary	Progression-Free Survival (PFS)	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.	6mo after the last enrolled patient
Secondary	Overall Survival (OS)	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.	6mo after the last enrolled patient
Secondary	Disease Control Rate	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.	Up to 6 weeks from randomization
Secondary	Safety	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.	6 mo after the last enrolled patients