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

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Brief Title

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

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

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate

Secondary Outcome

 Progression-Free Survival (PFS)

Condition

Biliary Cancer

Intervention

Irinotecan

Study Arms / Comparison Groups

 IP (irinotecan and cisplatin)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

January 2013

Completion Date

December 2018

Primary Completion Date

December 2018

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;
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lucas V dos Santos, MD, +5517-81544670, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01859728

Organization ID

GAMBIT201201


Responsible Party

Sponsor

Study Sponsor

Hospital de Cancer de Barretos - Fundacao Pio XII


Study Sponsor

Lucas V dos Santos, MD, Study Chair, Barretos Cancer Hospital


Verification Date

August 2015