Biliary CancerPhase 2GAMBITNCT01859728
GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
A Phase 2 study testing Irinotecan, Cisplatin and Gemcitabine in people with Biliary Cancer, run by Hospital de Cancer de Barretos - Fundacao Pio XII at 1 site in Brazil.
Trial summary
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Cancer
- What is being tested?
- Irinotecan, Cisplatin and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Barretos Cancer Hospital
Barretos, São Paulo, 14784400
Lucas V. dos Santos, M.D., +551781544670, lucasvsantos@yahoo.com
Kathia C Abdalla, MD, +551733216600 ext. 6829, kathia.abdalla@hcancerbarretos.com.br
About this study
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
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
- Conditions
- Biliary Cancer
- Being tested
- Irinotecan, Cisplatin, Gemcitabine
- Keywords
- biliary cancer, irinotecan, cisplatin, gemcitabine
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called CPT-11
Irinotecan 65mg/m² D1 and D8 q21 days, until disease progression or unacceptable toxicity.
Given in association with standard hydration and anti-emetics.
CisplatinDrug
Also called CDDP
Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity.
Given in association with standard hydration and anti-emetics.
CisplatinDrug
Also called CDDP
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.
GemcitabineDrug
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 group | Role | What they receive |
|---|---|---|
| IP (irinotecan and cisplatin) | Experimental | 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. Receives: Drug: Irinotecan; Drug: Cisplatin |
| GC (gemcitabine and cisplatin) | Active comparator | 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. Receives: Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks from randomization
Secondary outcomes (4)
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.
Measured: 6mo after the last enrolled patient
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.
Measured: 6mo after the last enrolled patient
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.
Measured: Up to 6 weeks from randomization
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.
Measured: 6 mo after the last enrolled patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Cancer de Barretos - Fundacao Pio XII
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucas V dos Santos, MD, Study chair, Barretos Cancer HospitalKathia C Abdalla, MD, Principal investigator, Barretos Cancer HospitalJoao Paulo S N Lima, MD, PhD, Study director, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859728
- Sponsor's protocol ID
- GAMBIT201201
- Acronym
- GAMBIT
- Status last verified
- Aug 2015
- First submitted
- 14 May 2013
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01859728
- Acronym / sponsor ID
- GAMBIT / GAMBIT201201
- Conditions
- Biliary Cancer
- Keywords
- biliary cancer, irinotecan, cisplatin, gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hospital de Cancer de Barretos - Fundacao Pio XIIUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP (irinotecan and cisplatin) | Experimental | Drug: Irinotecan, Drug: CisplatinIrinotecan 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) | Active comparator | Drug: Cisplatin, Drug: GemcitabineGemcitabine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrinotecanAlso: CPT-11Irinotecan 65mg/m² D1 and D8 q21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics. | Drug | IP (irinotecan and cisplatin) |
| CisplatinAlso: CDDPCisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics. | Drug | IP (irinotecan and cisplatin) |
| CisplatinAlso: CDDPCisplatin 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. | Drug | GC (gemcitabine and cisplatin) |
| GemcitabineGemcitabine 1000mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics. | Drug | GC (gemcitabine and cisplatin) |
Primary outcome
Overall Response Rate
Time frame: 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.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 6mo after the last enrolled patient
Overall Survival (OS)
Time frame: 6mo after the last enrolled patient
Disease Control Rate
Time frame: Up to 6 weeks from randomization
Safety
Time frame: 6 mo after the last enrolled patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
Related trials for Biliary Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas V dos Santos, MD study chair
Barretos Cancer Hospital
Kathia C Abdalla, MD principal investigator
Barretos Cancer Hospital
Joao Paulo S N Lima, MD, PhD study director
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Cisplatin and Gemcitabine in people with Biliary Cancer, run by Hospital de Cancer de Barretos - Fundacao Pio XII at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas V dos Santos, MD (+5517-81544670, lucasvsantos@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Up to 24 weeks from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.