Neoadjuvant Chemoradiotherapy (Gemcitabine/Cisplatin and Taxotere) With or Without Co-Administration of ZD 1839 (Iressa) for Stage IIIA (N2) and Selective Stage IIIB Non-Small Cell Lung Cancer: Phase I-II Study

NCT00062270 Phase 1/Phase 2 COMPLETED

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 1/Phase 2
Status	COMPLETED
Start date	2003-05
Completion	2004-09

Conditions

• Lung Cancer

Interventions

• cisplatin
• docetaxel
• gefitinib
• gemcitabine hydrochloride
• conventional surgery
• neoadjuvant therapy
• radiation therapy

Primary outcomes

• Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.

Countries

United States