Title
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin
Phase
Phase 2Lead Sponsor
Baptist HealthStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Lung CancerIntervention/Treatment
paclitaxel carboplatin ...Study Participants
NoneRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.
OBJECTIVES:
Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT).
Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients.
Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines.
Determine the feasibility of patient-specific dose escalation using this regimen in these patients.
Determine the quality of life and symptom distress in these patients on this regimen.
OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT).
Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks.
Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels.
Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.
DISEASE CHARACTERISTICS: Patients with unresected locally advanced non-small cell lung cancer Stage II, IIIA, or IIIB No evidence of hematogenous metastases No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure) No intrathoracic tumor recurrence following resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 130,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active or symptomatic cardiac disease No acute myocardial infarction within the past 6 months No angina No congestive heart failure No uncontrolled arrhythmias Cardiac ejection fraction greater than 50% Pulmonary: FEV1 at least 1.25 L AND DLCO at least 50% predicted Other: Not pregnant Fertile patients must use effective contraception Weight loss no greater than 5% within 3 months of diagnosis No other prior malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck radiotherapy Surgery: See Disease Characteristics
