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

NCT00268255 | Withdrawn Phase 1 DMC

• 4 other identifiers: CDR0000447160WSU-D-2820WSU-HIC-100304M1FZENECA-1839US/0258
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer; adenocarcinoma of the lung

Interventions

gefitinib DRUG

adjuvant therapy PROCEDURE

enzyme inhibitor therapy PROCEDURE

neoadjuvant therapy PROCEDURE

protein tyrosine kinase inhibitor therapy PROCEDURE

radiation therapy PROCEDURE

radiosensitization PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• AstraZeneca: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar; Adenocarcinoma of Lung

Interventions

Gefitinib; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Andrew T. Turrisi, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 22, 2005
• Last Updated: April 16, 2013

Record last verified: 2013-04