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

NCT01859728 | Unknown Phase 2 DMC

• 1 other identifier: GAMBIT201201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Cancer

Keywords

biliary cancer; irinotecan; cisplatin; gemcitabine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-Free Survival (PFS)

  6mo after the last enrolled patient

• Overall Survival (OS)

  6mo after the last enrolled patient

• Disease Control Rate

  Up to 6 weeks from randomization

• Safety

  6 mo after the last enrolled patients

Other Outcomes (1)

• Biomarker evaluation

  Baseline

Study Arms (2)

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.

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.

Drug: Cisplatin; Drug: Gemcitabine

Interventions

Irinotecan DRUG

Irinotecan 65mg/m² D1 and D8 q21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.

Also known as: CPT-11

IP (irinotecan and cisplatin)

Cisplatin DRUG

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

Also known as: CDDP

IP (irinotecan and cisplatin)

Gemcitabine DRUG

Gemcitabine 1000mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.

GC (gemcitabine and cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital de Cancer de Barretos - Fundacao Pio XII: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Irinotecan; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lucas V dos Santos, MD

  Barretos Cancer Hospital

  STUDY CHAIR

• Kathia C Abdalla, MD

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Joao Paulo S N Lima, MD, PhD

  Barretos Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Lucas V dos Santos, MD

CONTACT

+5517-81544670; lucasvsantos@yahoo.com

Kathia C Abdalla, MD

CONTACT

+551733216600; kathia.abdalla@hcancerbarretos.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 22, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 18, 2018

Record last verified: 2015-08

Locations

BR (1)