Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments gemcitabine, capecitabine, erlotinib
Phase phase 3
Target EGFR
Sponsor PD Dr. med. Volker Heinemann
Collaborator Roche Pharma AG
Start date June 2006
End date December 2011
Trial size 280 participants
Trial identifier NCT00440167, RC-57 crossover

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
capecitabine
Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")
erlotinib
Erlotinib 150 mg/d oral, daily without break
(Active Comparator)
gemcitabine
Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
erlotinib
Erlotinib 150 mg/d oral, daily without break

Primary Outcomes

Measure
TTF2
time frame: approximate 6 months after first line treatment

Secondary Outcomes

Measure
TTF1
time frame: approximate 6 months after randomization
Remission Rate
time frame: approximate 6 months after randomization
Overall Survival
time frame: 42 months after randomization
Clinical Benefit Response
time frame: approximate 6 months after randomization
Tumor marker CA19-9 characteristics
time frame: approximate 6 months after randomization
Quality of Life
time frame: approximate 6 months after randomization
Toxicity
time frame: approximate 6 months after randomization

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer
Principal investigator Volker Heinemann, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.