Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase I/II Study of Induction Gefitinib and Concurrent Radiotherapy in Patients With Previously Untreated, Medically Inoperable Stage I or II Non-Small Cell Lung Cancer
Verified date | April 2013 |
Source | Barbara Ann Karmanos Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Barbara Ann Karmanos Cancer Institute | AstraZeneca |
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