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

PD Dr. med. Volker Heinemann280 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Pancreatic Cancer

Interventions

Gemcitabine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

TTF2

Time to treatment failure, after 2nd line (crossover) therapy

Time frame: approximate 6 months after first line treatment