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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00466284
• Other study ID #: GGCP023/05-ML19497
• Status: Recruiting
• Phase: Phase 2
• First received: April 25, 2007
• Last updated: April 25, 2007
• Start date: January 2006

Study information

• Verified date: April 2007
• Source: Grupo Gallego de Cancer de Pulmon
• Contact: Joaquin Casal, MD
• Phone: 986811111
• Email: joaquin.casal.rubio[@]sergas.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Tarceva (erlotinib)

Locations

Country	Name	City	State
Spain	Grupo Gallego de Cancer de Pulmon	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Gallego de Cancer de Pulmon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate
Secondary	Progression free survival
Secondary	Overall survival
Secondary	Safety of Tarceva

External Links

•   GRUPO GALLEGO DE CANCER DE PULMON WEBSITE