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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baptist Health South Florida
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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