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S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer

NCT00075686 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 766

Last updated 2015-11-17

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas.

Conditions

Interventions

BIOLOGICAL

cetuximab

Loading dose: Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only). Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 \& days 1,8,15,22 of all subsequent cycles

DRUG

gemcitabine hydrochloride

1000mg/m2 IV over 30 minutes

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Philip A. Philip, MD, PhD, FRCP · Barbara Ann Karmanos Cancer Institute

  • Eileen O'Reilly, MD · Memorial Sloan Kettering Cancer Center

  • Ralph PW Wong, MD, FRCPC · CancerCare Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-05-31
Completion
2009-04-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT00075686 on ClinicalTrials.gov