Status:
UNKNOWN
Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine
Lead Sponsor:
PD Dr. med. Volker Heinemann
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimen...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years
- Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1)
- No option for resection with curative intent
- At least one measurable or not measurable lesion (according to RECIST)
- No previous chemotherapy or other systemic tumor therapy
- No previous radiation
- Performance-Status 0-2 according to WHO/ECOG
- Life expectancy of at least 3 months
- Adequate kidney-, liver- and bone marrow function, defined as
- Absolute neutrophil count \* 1,5 x 109/l
- Hemoglobin \* 8 g/dl
- Thrombocytes \* 100 x 109/l
- Bilirubin \* 2 x upper norm (with liver mets \< 5-fold)
- Serum Creatinine \* 1,25 x upper norm
- Creatinine clearance \> 30 ml/min (Cockroft/Gault)
- Transaminases \* 2,5 x upper norm (with liver mets \< 5-fold)
- Possibility of regular long-term follow-up
- Negative pregnancy test in women at childbearing age
- All patients must have signed an informed consent before study entry.
Exclusion
- Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri
- Clinically unstable CNS-metastases
- Known hypersensitivity against study medication
- Severe impairment of renal function (creatinine clearance \< 30 ml/min)
- Severe impairment of liver function (bilirubin \> 2,0 x above upper norm, transaminases \> 2,5 x upper norm, or with known liver metastasis \>5 x upper norm)
- Clinically relevant disease of the cardiovascular system or other vital organs
- Known polyneuropathy
- Known DPD-deficiency (screening not required)
- Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin
- Pregnancy, lactation or lack of reliable contraception in women at childbearing age
- Mental disease, drug- or alcohol abuse
- Participation in another clinical trial within the last 4 weeks
- All other diseases which may prevent adequate participation in the trial
- Indication of lack of compliance with study regulations
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00440167
Start Date
June 1 2006
End Date
December 1 2012
Last Update
July 9 2012
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