Spots Global Cancer Trial Database for Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

Study Description

Brief Summary: This phase II clinical trial studies how well combining different regimens of chemotherapy and gefitinib with radiation therapy work in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of non-small cell lung cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving different regimens of combination therapy together with gefitinib and radiation therapy may be an effective treatment for non-small cell lung cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To determine whether ZD1839 (gefitinib) at 250 mg orally every day administered concomitantly with radiotherapy after induction treatment consisting of paclitaxel, carboplatin, and ZD1839 among patients with inoperable stage III non-small cell lung cancer and Common Terminology Criteria (CTC) performance status 2 or poor risk performance status 0-1 is tolerable. II. To determine whether ZD1839 at 250 mg orally every day administered concomitantly with paclitaxel, carboplatin, and radiation after induction treatment consisting of paclitaxel, carboplatin, and ZD1839 among patients with inoperable stage III non-small cell lung cancer and CTC performance status 0-1 is tolerable. III. To determine the overall response rate, failure-free survival, and survival after treatment with induction chemotherapy with daily ZD1839, concomitant radiotherapy and daily ZD1839, and post-radiotherapy single agent daily ZD1839 among patients with CTC performance status 2 or poor risk performance status 0-1 and inoperable stage III non-small cell lung cancer. IV. To determine the overall response rate, failure-free survival, and survival after treatment with induction chemotherapy and daily ZD1839, concomitant chemoradiotherapy and daily ZD1839, and post-radiotherapy single agent daily ZD1839 among patients with CTC performance status 0-1 and inoperable stage III non-small cell lung cancer. V. To determine if elevated circulating epidermal growth factor receptor (EGFR) levels prior to treatment, as determined by either quantitative polymerase chain reaction (PCR) or direct enzyme-linked immunosorbent assay (ELISA) measurement, may predict for response to therapy with EGFR inhibitors. OUTLINE: All patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive therapy based on their assigned stratum. STRATUM I: Patients receive gefitinib orally (PO) daily for 7 weeks. Patients also undergo concurrent radiotherapy once daily 5 days a week for 7 weeks. STRATUM II: Patients receive gefitinib and radiotherapy as in stratum I concurrently with paclitaxel IV over 1 hour followed by carboplatin over 30 minutes once weekly for 7 weeks. Patients then receive gefitinib PO daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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