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Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

NCT00733746 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2019-10-21

Study results available
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Summary

PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

Conditions

Interventions

DRUG

erlotinib hydrochloride

oral administration

DRUG

gemcitabine hydrochloride

Intravenous administration

PROCEDURE

therapeutic conventional surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Peter W.T. Pisters, 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
2009-04-30
Primary Completion
2015-11-30
Completion
2019-06-15

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00733746 on ClinicalTrials.gov