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

Hellenic Oncology Research Group

Status and phase: Terminated; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT00564720

CT/06.13

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

1

Experimental group

Description:

GEM/TAR

Treatment:

Drug: Erlotinib

Drug: Gemcitabine

Drug: Gemcitabine

2

Experimental group

Description:

GEM/OX/TAR

Treatment:

Drug: Erlotinib

Drug: Oxaliplatin

Drug: Gemcitabine

Drug: Gemcitabine