Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Hellenic Oncology Research Group8 sites in 1 country140 target enrollmentDecember 2006

ConditionsPancreatic Cancer

InterventionsGemcitabine Erlotinib Oxaliplatin

DrugsGemcitabine Erlotinib Oxaliplatin

Overview

Phase: Phase 2
Intervention: Gemcitabine
Conditions: Pancreatic Cancer
Sponsor: Hellenic Oncology Research Group
Enrollment: 140
Locations: 8
Primary Endpoint: Overall Survival
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

March 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hellenic Oncology Research Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed pancreatic cancer.
•Measurable disease.
•Absence of ascites or obstructive jaundice.
•ECOG Performance Status 0-
•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 ≥
•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.