Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
18 Years
75 Years
Both
Cholangiocarcinoma
Trial Information
Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Principal Investigator
Ulrik Lassen, MD., PH.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rigshospitalet, Dept. of Oncology
Authority:
Denmark: Danish Medicines Agency
Study ID:
GEMOXEL cholangiocarcinoma
NCT ID:
NCT00350961
Start Date:
June 2004
Completion Date:
February 2008
Related Keywords:
- Cholangiocarcinoma
- Cholangiocarcinoma
- Fixed dose rate
- Gemcitabine
- Oxaliplatin
- Capecitabine
- Cholangiocarcinoma
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