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Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients

NCT00338039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2013-03-22

Study results available
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Summary

The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary endpoint is actuarial one-year survival.

The secondary objectives are:

* To evaluate the local tumor response in patients treated with the above regimen.
* To characterize the safety of the above regimen.

Conditions

Interventions

DRUG

Cetuximab

500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy.

DRUG

Gemcitabine

Induction Therapy: 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses. Chemotherapy Maintenance: 1 gm/m\^2/week over 100 minutes weekly for 3 weeks then 1 week off.

DRUG

Oxaliplatin

Induction Chemotherapy: 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses.

DRUG

Capecitabine

Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation.

RADIATION

Radiotherapy

Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.

Sponsors & Collaborators

Principal Investigators

  • Christopher H. Crane, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00338039 on ClinicalTrials.gov