Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PD Dr. med. Volker Heinemann
• Collaborator: Roche Pharma AG
• Treatments: Capecitabine; Erlotinib Hydrochloride; Gemcitabine

Criteria

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