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Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed

2014-08-27 03:55:40 | BioPortfolio

Summary

RATIONALE: Biological therapies such as gefitinib may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether gefitinib is effective in delaying the recurrence of non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in treating patients who have undergone surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.

Description

OBJECTIVES:

Primary

- Compare the overall survival of patients with completely resected primary stage IB, II, or IIIA non-small cell lung cancer treated with gefitinib vs placebo.

Secondary

- Compare the disease-free survival of patients treated with these regimens.

- Determine the prognostic significance of epidermal growth factor receptor expression, phosphorylation, and mutations in the primary tumor in predicting relative impact of gefitinib on survival of these patients.

- Establish a comprehensive tumor bank linked to a clinical database for further study of molecular markers in patients treated with these regimens.

- Determine the toxicity of gefitinib in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (IB vs II vs IIIA), histological subtype (squamous cell vs others), postoperative radiotherapy (yes vs no), prior adjuvant platinum-based chemotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral gefitinib daily, unless otherwise directed by the investigator.

- Arm II: Patients receive oral placebo daily, unless otherwise directed by the investigator.

Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, 3 months, and every 3 months for 30 months after randomization, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,242 patients (621 per treatment arm) will be accrued for this study within 3.5 years.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

gefitinib, adjuvant therapy

Location

Veterans Affairs Medical Center - Tucson
Tucson
Arizona
United States
85723

Status

Active, not recruiting

Source

NCIC Clinical Trials Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:40-0400

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Medical and Biotech [MESH] Definitions

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Combined chemotherapy and radiotherapy given to augment some other form of treatment such as surgery. It is commonly used in the therapy of cancer.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

A performance measure for rating the ability of a person to perform usual activities, evaluating a patient's progress after a therapeutic procedure, and determining a patient's suitability for therapy. It is used most commonly in the prognosis of cancer therapy, usually after chemotherapy and customarily administered before and after therapy. It was named for Dr. David A. Karnofsky, an American specialist in cancer chemotherapy.

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