Status:
COMPLETED
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Swiss National Science Foundation
Swiss Cancer League
Conditions:
Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplat...
Detailed Description
Primary Objectives: * Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC * Phase II: to assess any a...
Eligibility Criteria
Inclusion
- Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas
- Disease non-resectable and locally advanced or metastatic
- Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline ≥ 1.5 x upper limit of normal (ULN)
- Age \>18 years
- Karnofsky performance status ≥ 60%
- Life expectancy of at least 3 months
- Written informed consent
- Willing and able to comply with the protocol for the duration of the study
Exclusion
- Prior chemotherapy for pancreatic cancer
- Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of inclusion
- Known CNS metastases at the time of enrollment
- Neutrophil count ≤ 1.5 x109/l, platelet count ≤100 x109/l, hemoglobin ≤ 10g/dl
- Serum creatinine \> 1.25 x ULN
- ASAT, ALAT and alkaline phosphatase \> 2.5 ULN or \> 5 ULN in the presence of liver metastasis, Bilirubin \> 1.5 ULN (after treatment of obstructive jaundice eg. stent)
- Pregnant or breast feeding women (women of childbearing potential must have a negative pregnancy test at baseline)
- Men and women of reproductive potential who are not using an effective method of contraception
- Clinically significant cardiac disease (NYHA III-IV) or myocardial infarction within the last 12 months
- Neurological disease with dys-/paraesthesias \> grade 1 according to NCI CTC
- Any serious concomitant disorder incompatible with the trial (in the judgement of the investigator)
- Psychiatric disability thought to be clinically significant in the opinion of the investigator precluding informed consent or interfering with compliance
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00744640
Start Date
October 1 2005
End Date
December 1 2009
Last Update
January 12 2010
Active Locations (8)
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1
Cantonal Hospital Bruderholz
Bruderholz, Basel-Landschaft, Switzerland
2
Cantonal Hospital Liestal
Liestal, Basel-Landschaft, Switzerland
3
St. Clara Hospital
Basel, Switzerland
4
University Hospital Basel
Basel, Switzerland