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

NCT00564720 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-02-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles

DRUG

Gemcitabine

Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles

DRUG

Erlotinib

Erlotinib 100 mg by mouth (p.o.), daily until disease progression

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Vassilis Georgoulias, MD · University Hospital of Crete, Dep of Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Greece

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564720 on ClinicalTrials.gov