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
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: carboplatin (Drug); paclitaxel (Drug); chemotherapy (Procedure); radiation therapy (Procedure)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: Baptist-South Miami Regional Cancer Program Official(s) and/or principal investigator(s):
Andre A. Abitbol, MD, Study Chair, Affiliation: Baptist-South Miami Regional Cancer Program
Summary
RATIONALE: 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.
Clinical Details
Official title:
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
Study design: Interventional, Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Baptist Hospital of Miami, Miami, Florida 33176-2197, United States
Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
March 2000
Last updated: February 20, 2007
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