NCT00268255WithdrawnPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
Study Overview
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.
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 stage I or II non-small cell lung cancer. (Phase I)
- Determine the efficacy of gefitinib when given for 6 weeks prior to and concurrent with radiotherapy, in terms of objective response rate (partial and complete response), in these patients.
Secondary
- Determine the 3-month tumor response (complete and partial response) in patients treated with this regimen.
- Determine the 6-week response rate in patients treated with this regimen.
- Determine the local disease control rate (complete and partial response, stable disease) in patients treated with this regimen.
- Determine the local progression-free survival and disease-specific survival (cancer vs co-morbid disease) of patients treated with this regimen.
- Determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.
- Determine the acute and late radiation toxic effects to organs at risk in patients treated with this regimen.
- Determine the safety profile of gefitinib in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •No restrictions
- •Creatinine ≤ CTC grade 2
- •No clinically active interstitial lung disease
- •Chronic, stable, asymptomatic radiographic changes allowed
- •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
- •Recovered from prior surgery
- •No concurrent ophthalmic surgery
- •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
- •Phenobarbital
- •Hypericum perforatum (St. John's wort)
- •No concurrent systemic retinoids
Exclusion Criteria
- Not provided
Investigators
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