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

NCT ID: NCT00642733

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

erlotinib [Tarceva]

Intervention Type DRUG

100mg po daily

gemcitabine

Intervention Type DRUG

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

Interventions

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erlotinib [Tarceva]

100mg po daily

Intervention Type DRUG

gemcitabine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Morelia, , Mexico

Site Status

Tijuana, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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ML21285

Identifier Type: -

Identifier Source: org_study_id

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