S0022:Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2005-03-01
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IIIB non-small cell lung cancer

• Adenocarcinoma

• Large cell carcinoma

• Squamous cell carcinoma

• Pathologically or radiographically documented positive N3 nodes

• No positive supraclavicular or scalene lymph nodes with disease extending into the cervical region OR

• T4 tumor invading any of the following:

• Mediastinum

• Heart

• Great vessels

• Trachea

• Esophagus

• Vertebral body

• Carina

• No brain, contralateral chest, liver, or adrenal metastases

• No more than 1 parenchymal lesion

• No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap

• No pericardial effusions

• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Creatinine clearance at least 50 mL/min

Pulmonary:

• One of the following:

• FEV1 at least 2.0 L

• Predicted FEV1 of contralateral lung greater than 800 mL

• Predicted post-treatment FEV1 at least 1.0 L

Other:

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent growth factors during induction chemoradiotherapy

Chemotherapy:

• No prior chemotherapy for lung cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for lung cancer

Surgery:

• No prior surgical resection of lung cancer

• Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed