Back to resultsGAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer (GAMBIT)
Primary Purpose
Biliary Cancer
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Irinotecan
Cisplatin
Cisplatin
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Cancer focused on measuring biliary cancer, irinotecan, cisplatin, gemcitabine
Eligibility 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;
Sites / Locations
- Barretos Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IP (irinotecan and cisplatin)
GC (gemcitabine and cisplatin)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT01859728
First Posted
May 14, 2013
Last Updated
January 17, 2018
Sponsor
Hospital de Cancer de Barretos - Fundacao Pio XII
1. Study Identification
Unique Protocol Identification Number
NCT01859728
Brief Title
GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Cancer de Barretos - Fundacao Pio XII
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Cancer
Keywords
biliary cancer, irinotecan, cisplatin, gemcitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IP (irinotecan and cisplatin)
Arm Type
Experimental
Arm 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.
Arm Title
GC (gemcitabine and cisplatin)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11
Intervention Description
Irinotecan 65mg/m² D1 and D8 q21 days, until disease progression or unacceptable toxicity.
Given in association with standard hydration and anti-emetics.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity.
Given in association with standard hydration and anti-emetics.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity.
Given in association with standard hydration and anti-emetics.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
Up to 24 weeks from randomization
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
6mo after the last enrolled patient
Title
Overall Survival (OS)
Description
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.
Time Frame
6mo after the last enrolled patient
Title
Disease Control Rate
Description
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.
Time Frame
Up to 6 weeks from randomization
Title
Safety
Description
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.
Time Frame
6 mo after the last enrolled patients
Other Pre-specified Outcome Measures:
Title
Biomarker evaluation
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas V dos Santos, MD
Phone
+5517-81544670
Email
lucasvsantos@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kathia C Abdalla, MD
Phone
+551733216600
Ext
6829
Email
kathia.abdalla@hcancerbarretos.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas V dos Santos, MD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kathia C Abdalla, MD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joao Paulo S N Lima, MD, PhD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
SP
ZIP/Postal Code
14784400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas V. dos Santos, M.D.
Phone
+551781544670
Email
lucasvsantos@yahoo.com
First Name & Middle Initial & Last Name & Degree
Kathia C Abdalla, MD
Phone
+551733216600
Ext
6829
Email
kathia.abdalla@hcancerbarretos.com.br
First Name & Middle Initial & Last Name & Degree
Kathia C Abdalla, MD
First Name & Middle Initial & Last Name & Degree
Arinilda C Bragagnoli, MD
12. IPD Sharing Statement
Learn more about this trial
GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
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