GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
NCT ID: NCT01859728
Last Updated: 2018-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2013-01-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IP (irinotecan and 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.
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.
GC (gemcitabine and 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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
ALL
No
Sponsors
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Hospital de Cancer de Barretos - Fundacao Pio XII
OTHER
Responsible Party
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Principal Investigators
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Lucas V dos Santos, MD
Role: STUDY_CHAIR
Barretos Cancer Hospital
Kathia C Abdalla, MD
Role: PRINCIPAL_INVESTIGATOR
Barretos Cancer Hospital
Joao Paulo S N Lima, MD, PhD
Role: STUDY_DIRECTOR
Barretos Cancer Hospital
Locations
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Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GAMBIT201201
Identifier Type: -
Identifier Source: org_study_id
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