Status:
COMPLETED
Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Henrik Jensen, Dept. of Oncology, Vejle Sygehus, Vejle, Denmark
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00350961
Start Date
June 1 2004
End Date
February 1 2008
Last Update
August 26 2008
Active Locations (2)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
Vejle Sygehus
Vejle, Denmark, 7100