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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Grupo Gallego de Cancer de Pulmon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466284
First Posted: April 27, 2007
Last Update Posted: April 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Grupo Gallego de Cancer de Pulmon
  Purpose

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


Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Tarceva (erlotinib) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Grupo Gallego de Cancer de Pulmon:

Primary Outcome Measures:
  • Objective response rate

Secondary Outcome Measures:
  • Progression free survival
  • Overall survival
  • Safety of Tarceva

Estimated Enrollment: 46
Study Start Date: January 2006
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466284


Contacts
Contact: Joaquin Casal, MD 986811111 ext 645 joaquin.casal.rubio@sergas.es

Locations
Spain
Grupo Gallego de Cancer de Pulmon Recruiting
Santiago de Compostela, A Coruña, Spain, 15701
Contact: Joaquin Casal, MD       joaquin.casal.rubio@sergas.es   
Sponsors and Collaborators
Grupo Gallego de Cancer de Pulmon
Investigators
Principal Investigator: Joquin Casal, MD GGCP
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00466284     History of Changes
Other Study ID Numbers: GGCP023/05-ML19497
First Submitted: April 25, 2007
First Posted: April 27, 2007
Last Update Posted: April 27, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action