A Study Of First Line Treatment With Tarceva (Erlotinib) In Combination With Gemcitabine In Patients With Locally Advanced Unresectable Or Metastatic Pancreatic Cancer

Study Overview

A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

N/A

Pancreatic Cancer

DRUG: erlotinib [Tarceva]
DRUG: gemcitabine

ML21285

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-03-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-08-22
First Submitted that Met QC Criteria 2008-03-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-08-24
First Posted (ESTIMATED) 2008-03-25	Results First Posted N/A	Last Verified 2016-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1	DRUG: erlotinib [Tarceva] 100mg po daily DRUG: gemcitabine 1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

DRUG: erlotinib [Tarceva]

100mg po daily

DRUG: gemcitabine

1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle

Primary Outcome Measures	Measure Description	Time Frame
Overall survival; time to progression		6 months

Secondary Outcome Measures	Measure Description	Time Frame
Duration of response; disease-free survival		Event driven
AEs, lab parameters		Throughout study

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

adult patients, >=18 years of age;
pancreatic cancer, surgically unresectable or with metastases;
no previous chemotherapy (except concomitant with radiotherapy);
ECOG 0-2.

pancreatic cancer without histologic or cytologic confirmation;
surgical resection possible;
previous chemotherapy not concomitant with radiotherapy;
ECOG 3-4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Clinical Trials, Hoffmann-La Roche

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record