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Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

NCT00026338 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 569

Last updated 2020-04-02

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.

Conditions

Interventions

DRUG

erlotinib hydrochloride

150 mg po daily

DRUG

gemcitabine hydrochloride

1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Malcolm J. Moore, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-10-29
Primary Completion
2004-09-17
Completion
2009-02-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Germany
  • Greece
  • Hong Kong
  • Israel
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Singapore
  • United Kingdom

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 NCT00026338 on ClinicalTrials.gov