Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically proven newly diagnosed advanced primary non-small
cell lung cancer (NSCLC), including the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified carcinoma OR

- Recurrent disease after prior surgery and/or radiotherapy

- Stage IIIB disease

- T4 lesion due to malignant pleural effusion OR

- Stage IV disease

- Any T, any N, M1 (distant metastasis, including lesions in multiple lobes of the
ipsilateral lung)

- Measurable or evaluable disease

- Pleural effusions, ascites, and laboratory parameters not considered as only
evidence of disease

- Must be outside prior radiated field or area of prior surgical resection or new
lesion must be present

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

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

- Hemoglobin at least 9 g/dL

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN

- Alkaline phosphatase no greater than 2 times ULN

Renal:

- Creatinine no greater than ULN

- Creatinine clearance at least 50 mL/min

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No peripheral neuropathy (motor or sensory) of grade 2 or greater

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or stage I/II cancer in
complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy for NSCLC

Chemotherapy:

- No prior systemic chemotherapy for NSCLC

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 2 weeks since prior thoracic or other major surgery and recovered