Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Erlotinib Hydrochloride; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed pancreatic cancer.

• Measurable disease.

• Absence of ascites or obstructive jaundice.

• ECOG Performance Status 0-2.

• Adequate liver kidney and bone marrow function.

• Written informed consent.

Exclusion Criteria:

• Chronic diarrheic syndrome.

• Uncontrolled brain metastases after radiation.

• Liver infiltration over 50%.

• Peripheral neuropathy ≥ 2.

• No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.

• No active uncontrolled infection.

• Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

• Women who are pregnant or lactating.