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Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer

NCT00395252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2015-10-02

No results posted yet for this study

Summary

This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.

Conditions

  • Adenocarcinoma

Interventions

DRUG

Cetuximab (Erbitux®) and Gemcitabine

Cetuximab: Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly for up to 6 months (treatment duration: 24 weeks) Gemcitabine: 1000 mg/m2 administered on days 1, 8, 15 Cycles will be repeated on day 29, up to 6 treatment cycles will be administered Mode of administration: Intravenous infusion

Sponsors & Collaborators

  • Carmen Schade-Brittinger

    lead OTHER

Principal Investigators

  • Thomas M Gress, Prof.Dr. med · Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-11-30
Completion
2012-01-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT00395252 on ClinicalTrials.gov