Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

April 25, 2007 updated by: Grupo Gallego de Cancer de Pulmon

Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer

A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.

STUDY OBJECTIVES

Primary: Objective response rate

Secondary: Progression free survival, Overall survival and Safety of Tarceva

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study Design: Phase II trial, open label, non-randomized and multicenter.

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008

Study Type

Interventional

Enrollment

46

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Spain
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15701

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years.
  • Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
  • Measurable disease.
  • Written informed consent must be obtained prior to the inclusion into the trial.
  • Karnofsky performance status of 80%.
  • Patients must have been treated with no prior chemotherapy or radioterapy.

  • Patients must have adequate bone marrow, liver and renal function.

    • Bone Marrow: WBC > 3000 x 103/mm3,
    • Platelets > 100 x 103/mm3,
    • Hgb > 10.0 gm/dl,
    • ANC >1500 x 103/mm3,
    • Hepatic:Bilirubin < 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase < 5 x normal,
    • Renal:Creatinine < 1.5 mg/dl (132 µmol/l).

Exclusion Criteria:

  • Female patients who are pregnant or lactating.
  • Patients who have used other investigational agents within 21 days prior to study entry.
  • Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
  • Significant comorbidity.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response rate

Secondary Outcome Measures

Outcome Measure
Overall survival
Progression free survival
Safety of Tarceva

Collaborators and Investigators

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

Sponsor

Grupo Gallego de Cancer de Pulmon

Investigators

  • Principal Investigator: Joquin Casal, MD, GGCP

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

April 27, 2007

Last Update Submitted That Met QC Criteria

April 25, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGCP023/05-ML19497

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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