RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
Squamous Cell Lung Cancer large cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer	Drug: carboplatin  Drug: paclitaxel  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: radiosensitization	Phase I Phase II

Further Study Details: 

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 10/28/04.)
• Determine the 12-month survival rate in patients treated with this regimen. (Phase II)
• 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.

• 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. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 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.

Genders Eligible for Study:  Both

Criteria

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

Florida
      University of Florida Shands Cancer Center, Gainesville,  Florida,  32610-0232,  United States; Recruiting
Missouri
      Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
Ohio
      Akron City Hospital at Summa Health System, Akron,  Ohio,  44304,  United States; Recruiting
Pennsylvania
      Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026,  United States; Recruiting
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting
      John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown,  Pennsylvania,  18105-1556,  United States; Recruiting
Wisconsin
      Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse,  Wisconsin,  54601,  United States; Recruiting

Study chairs or principal investigators

Jeffrey Bradley, MD,  Study Chair,  Barnes-Jewish Hospital   

Study ID Numbers:  CDR0000068850; RTOG-L-0117; NCT00023673
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00023673
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08