Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with gefitinib and to see how well they work in treating patients with inoperable stage I or stage II non-small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: AstraZeneca
• Treatments: Enzyme Inhibitors; Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC)

• Any non-small cell histology allowed

• T1-3, N0* disease

• No metastatic disease

• Refused or ineligible for surgery

• Measurable disease, defined as lesion diameter ≤ 5 cm NOTE: *No evidence of N1 or N2 disease by positron emission tomography (PET) scan or any histological means (mediastinoscopy, thoracotomy, transbronchial, tracheal aspirations, or transesophageal aspiration by endoscopic ultrasound guidance

PATIENT CHARACTERISTICS:

Performance status

• Any performance status

Life expectancy

• At least 1 year

Hematopoietic

• No restrictions

Hepatic

• No restrictions

Renal

• Creatinine ≤ CTC grade 2

Pulmonary

• No clinically active interstitial lung disease

• Chronic, stable, asymptomatic radiographic changes allowed

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective nonhormonal contraception

• No known severe hypersensitivity to gefitinib or any of the excipients of this product

• No other malignancy within the past 5 years except basal cell cancer or carcinoma in situ of the cervix

• No active or uncontrolled infection

• No uncontrolled systemic disease

• No psychiatric illness or other severe medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

Radiotherapy

• No prior radiotherapy to the chest or mediastinum

• No concurrent elective nodal irradiation

Surgery

• Recovered from prior surgery

• No concurrent ophthalmic surgery

Other

• Recovered from all other prior anticancer therapy (alopecia allowed)

• More than 30 days since prior nonapproved or investigational agents

• No concurrent CYP3A4 inducers, including any of the following:

• Phenytoin

• Carbamazepine

• Barbiturates

• Rifampin

• Phenobarbital

• Hypericum perforatum (St. John's wort)

• No concurrent systemic retinoids