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

This study is currently recruiting participants.

Verified by Grupo Gallego de Cancer de Pulmon, April 2007

Sponsored by:	Grupo Gallego de Cancer de Pulmon
Information provided by:	Grupo Gallego de Cancer de Pulmon
ClinicalTrials.gov Identifier:	NCT00466284

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466284

Contacts

Contact: Joaquin Casal, MD

986811111 ext 645

joaquin.casal.rubio@sergas.es

Locations

Spain, a CORUÑA
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:

GRUPO GALLEGO DE CANCER DE PULMON WEBSITE This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GGCP023/05-ML19497
Study First Received:	April 25, 2007
Last Updated:	April 25, 2007
ClinicalTrials.gov Identifier:	NCT00466284
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009