Status:
WITHDRAWN
Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity profile and maximum tolerated dose of radiotherapy when given in combination with gefitinib in patients with previously untreated, medically inoperable s...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00268255
Last Update
April 16 2013
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