• Maximum tolerated dose [ Designated as safety issue: Yes ]
  
• Percentage of patients who survive at least 12 months [ Designated as safety issue: No ]
  

• Toxicity [ Designated as safety issue: Yes ]
  
• Partial organ tolerance doses for lung and esophagus [ Designated as safety issue: Yes ]
  
• Complete response rate at 3 months after therapy [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)
• Determine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)
• Determine the toxicity of this regimen in these patients.
• Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen.
• Determine the complete response rate in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.

• Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.

Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity.

• Phase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3-5 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I [closed to accrual as of 10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.

DISEASE CHARACTERISTICS:

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

  • Squamous cell carcinoma
  • Adenocarcinoma
  • Large cell carcinoma
  • Non-small cell carcinoma not otherwise specified
• All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields
• Measurable disease on 3-dimensional planning CT scan
• No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma
• No stage IV or recurrent disease
• No distant metastases or supraclavicular lymph node involvement
• No significant atelectasis (i.e., atelectasis of an entire lung)
• No pleural effusions, pericardial effusions, or superior vena cava syndrome
• No lung cancer within the past 2 years
• Ineligible for currently open RTOG phase III lung protocols

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 mg/dL
• AST less than 2 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Pulmonary:

• FEV_1 at least 1.0 L

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No weight loss greater than 5% in the past 6 months
• No other malignancy within the past year except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic response modifiers for current lung cancer
• At least 5 years since prior biologic response modifiers

Chemotherapy:

• No prior chemotherapy for current lung cancer
• At least 5 years since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to the thorax

Surgery:

• No prior complete tumor resection