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: Randomized phase II trial to compare the effectiveness of three different regimens of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be removed during surgery.

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

Further Study Details: 

OBJECTIVES: I. Compare survival of patients with stage IIIA or IIIB unresectable non-small cell lung cancer treated with one of three different combined modality regimens of paclitaxel, carboplatin, and radiotherapy. II. Compare the safety and toxicity of these treatment regimens in these patients. III. Compare the relapse free survival rate in these patients treated with these regimens.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 every 3 weeks for 2 courses, followed by radiotherapy 5 times a week for 7 weeks beginning on day 42. Arm II: Patients receive paclitaxel and carboplatin as in arm I followed by radiotherapy 5 times a week, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes weekly for 7 weeks beginning on day 42. Arm III: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7 weeks beginning on day 1, followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and radiotherapy. Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 264 patients (88 per treatment arm) will be accrued for this study within 20 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) if not medically operable; Stage IIIB (any T, N3, M0 or T4, any N, M0); Radiographic evidence of mediastinal lymph nodes at least 2.0 cm in the largest diameter sufficient to stage N2 or N3 disease; If largest mediastinal node is less than 2.0 cm in diameter and is the basis for stage III disease, then at least one node must be histologically or cytologically confirmed positive
• Any of the following histologies allowed: Squamous cell carcinoma; Adenocarcinoma (including bronchoalveolar cell); Large cell anaplastic carcinoma (including giant and clear cell carcinomas); Poorly differentiated NSCLC
• No metastatic disease
• Patients with tumors adjacent to a vertebral body allowed if all gross disease can be encompassed in the radiation boost field (boost volume must be limited to less than 50% of the ipsilateral lung volume)
• Pleural effusions that are a transudate, cytologically negative, and non-bloody are allowed if tumor can be encompassed within reasonable field of radiotherapy
• Pleural effusions that can be seen on chest CT but not on chest x-ray and are too small to tap are allowed
• No brain metastases by MRI or CT scan
• No prior total surgical resection

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent colony stimulating factors (i.e., filgrastim (G-CSF) or sargramostim (GM-CSF)); No concurrent immunotherapy; Concurrent epoetin alfa allowed
• Chemotherapy: No prior systemic chemotherapy; No other concurrent chemotherapy
• Endocrine therapy: No concurrent hormonal agents except for nondisease related conditions (e.g., insulin for diabetes); Concurrent steroids administered for adrenal failure or septic shock allowed; Concurrent glucocorticosteroids as antiemetics allowed
• Radiotherapy: No prior radiotherapy to the thorax
• Surgery: See Disease Characteristics; At least 3 weeks since formal exploratory thoracotomy and recovered; At least 1 week since prior diagnostic thoracoscopy
• Other: No other concurrent anticancer drugs

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: Granulocyte count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 8 g/dL (transfusion or epoetin alfa allowed)
• Hepatic: Bilirubin less than 1.5 times normal
• Renal: Creatinine clearance greater than 50 mL/min
• Cardiovascular: No history of uncontrolled serious cardiac disease; No myocardial infarction within the past 6 months; No congestive heart failure; No unstable angina; No clinically significant pericardial effusion or arrhythmia
• Pulmonary: FEV1 greater than 800 mL; Post obstructive pneumonia allowed
• Other: No other active concurrent or prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix; No other serious medical or psychiatric illness that would preclude study No active serious infection; No prior significant allergic reactions to drugs containing Cremophor (e.g., cyclosporine or vitamin K); No weight loss of more than 10% within 3 months prior to diagnosis; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States
      Morristown Memorial Hospital, Morristown,  New Jersey,  07962-1956,  United States
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States

Study chairs or principal investigators

Nathan Levitan,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000068252; CWRU-LAMP-1598; NCI-G00-1867; ACR-427; BMS-CWRU-LAMP-1598; CWRU-099834
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006378
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08