Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine
- Registration Number
- NCT00440167
- Lead Sponsor
- PD Dr. med. Volker Heinemann
- 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 experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 280
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm A Capecitabine - Arm B Gemcitabine - Arm A Erlotinib - Arm B Erlotinib -
- Primary Outcome Measures
Name Time Method TTF2 approximate 6 months after first line treatment Time to treatment failure, after 2nd line (crossover) therapy
- Secondary Outcome Measures
Name Time Method Quality of Life approximate 6 months after randomization TTF1 approximate 6 months after randomization Time to treatment failure
Remission Rate approximate 6 months after randomization Toxicity approximate 6 months after randomization Overall Survival 42 months after randomization Clinical Benefit Response approximate 6 months after randomization Tumor marker CA19-9 characteristics approximate 6 months after randomization