Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma

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Brief Title

Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma

Official Title

Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma

Brief Summary

      In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No
      standard treatment exists for patients with advanced cholangiocarcinoma, and improved
      systemic treatments are needed.

      Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers
      and several different regimens are well tolerated and active, especially in upper
      gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer.

      The triplet combination of these agents has not been studied, but a triplet combination of
      gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study.

      Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and
      warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown
      interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during
      therapy seems to be saturable.

      We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and
      capecitabine. This regimen could be feasible in an out-patients setting.

      The phase I part is a standard dose escalation study for patients with solid tumors. In the
      phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.
    

Detailed Description

      Design

      Open, non-randomized phase I/II study.

      Purpose:

      Phase I part To find MTD and RFTD for the combination of gemcitabine, oxaliplatin and
      capecitabine.

      Dose Escalating Schedule Dose level Dose Gemcitabine 10 mg/m2/min 600-1000 mg/m2 day 1 and 14
      Capecitabine p.o. x 2 daily. 1000-1250 mg/m2 day 1-7 and 14-21 Oxaliplatin 60-80 mg/m2day 1
      and 14 Drugs: G C O Level 1 600 1000 60 Level 2 800 1000 60 Level 3 1000 1000 60 Level 4 1000
      1250 60 Level 5 1000 1250 80 Level 6 1200 1250 80 Start level: Level 1, 3 patients per level

      Phase II part The primary endpoint is the objective response rate The secondary endpoint is
      toxicity, response duration and time to progression.

      Treatment:

      Gemcitabine Gemcitabine is given intravenously on day 1 and 14 with a fixed dose rate of 10
      mg/m2/min.

      Oxaliplatin Oxaliplatin is given intravenously on day 1 and 14 as a 2 hours infusion.

      Capecitabine Capecitabine is given orally and administered in tablets of 150 mg and 500 mg.
      The dose is administered twice daily with 12 hours interval, in the morning and evening
      during or latest 30 minutes after a meal.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Response

Secondary Outcome

 Safety

Condition

Cholangiocarcinoma

Intervention

Gemcitabine


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

39

Start Date

June 2004

Completion Date

February 2008


Eligibility Criteria

        Inclusion Criteria:

          -  Histologically proven intra- or extrahepatic cholangiocarcinoma, papilla of the Vater
             or gallbladder carcinoma.

          -  PS 0-2

          -  Age 18-75

          -  Life expectancy > 12 weeks

          -  Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)

          -  Bilirubin < 1,5 x UNL

          -  Transaminases < 3 x UNL

          -  Normal renal function, Cr-EDTA clearance > 50 ml/min

          -  No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion

          -  No known DPD-deficiency

          -  No neuropathy

          -  No uncontrolled, severe concurrent medical disease

          -  Signed informed consent

        Exclusion Criteria:

          -  Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion

          -  Experimental therapy < 8 weeks prior to inclusion

          -  Uncontrolled, severe concurrent medical disease

          -  Prior malignancy during the last 5 years, except for non-melanoma skin cancer and
             carcinoma in situ cervix uteri.

          -  Allergy to gemcitabine, oxaliplatin or capecitabine

          -  Pregnancy or lactation
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ulrik Lassen, MD., PH.D., , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT00350961

Organization ID

GEMOXEL cholangiocarcinoma



Study Sponsor

Rigshospitalet, Denmark

Collaborators

 Henrik Jensen, Dept. of Oncology, Vejle Sygehus, Vejle, Denmark

Study Sponsor

Ulrik Lassen, MD., PH.D., Principal Investigator, Rigshospitalet, Dept. of Oncology


Verification Date

August 2008