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
18 Years
N/A
Both
Non-small Cell Lung Cancer
Trial Information
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
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.
OUTLINE: This is an open-label, multicenter, dose-escalation study of radiotherapy.
- Patients receive oral gefitinib once daily for 13 weeks. Patients also undergo
radiotherapy 5 days a week for 7 weeks beginning at week 7. Patients continue to
receive gefitinib alone after completion of radiotherapy in the absence of disease
progression or unacceptable toxicity.
Cohorts of 6-10 patients receive escalating doses of radiotherapy until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3
of 6 patients experience acute dose-limiting toxicity.
- Phase II: Patients receive oral gefitinib as in phase I and radiotherapy at the MTD
determined in phase I. After the completion of radiotherapy, patients continue to
receive gefitinib in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Andrew T. Turrisi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000447160
NCT ID:
NCT00268255
Start Date:
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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