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

Baptist Health South Florida

Status and phase

Unknown

Phase 2

Conditions

Lung Cancer

Treatments

Drug: paclitaxel

Drug: carboplatin

Radiation: radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00004253

CDR0000067500

BHM-99-64

BHM-L1

NCI-V99-1582

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: