• Measurability of lesions [ Designated as safety issue: No ]
• Objective response [ Designated as safety issue: No ]
• Best response [ Designated as safety issue: No ]
• Performance status [ Designated as safety issue: No ]
• Time to treatment failure [ Designated as safety issue: No ]
• Survival [ Designated as safety issue: No ]

• Measurability of lesions
• Objective response
• Best response
• Performance status
• Time to treatment failure
• Survival

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in 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. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer.

OBJECTIVES:

• Determine the overall survival of patients with limited stage small cell lung cancer treated with tirapazamine, cisplatin, and etoposide with concurrent thoracic radiotherapy followed by consolidation cisplatin and etoposide.
• Determine the time to treatment failure and response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
• Determine the toxicity of this regimen in these patients.
• Correlate baseline PAI-1, VEGF, OPN, and NDRG1 plasma markers with response and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Chemoradiotherapy: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks.
• Consolidation chemotherapy: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 months.

• Drug: cisplatin
• Drug: etoposide
• Drug: tirapazamine
• Radiation: radiation therapy

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)

  • Diagnosis by sputum cytology is allowed provided there is pathologic confirmation of disease
  • No positron-emission tomography scans for tumor staging

• Measurable or non-measurable disease by CT scan, MRI, or x-ray

  • Disease must be present outside the area of any prior surgical resection
• No metastatic disease, including brain metastases

• No malignant pericardial or pleural effusion*, defined as 1 of the following:

  • Cytologically positive effusion
  • Exudative effusion not attributable to other etiologies NOTE: *Patients with effusions too small to tap are eligible
• Patients must be offered participation in SWOG-S9925

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2 times ULN

Renal

• Creatinine clearance at least 50 mL/min* NOTE: *If calculated creatinine clearance is used, creatinine must be < 1.5 mg/dL

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Patients with significant clinical hearing loss must be willing to accept the potential for worsening of symptoms
• No grade 1 or greater symptomatic sensory neuropathy
• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for SCLC
• No concurrent filgrastim (G-CSF) during radiotherapy administration

Chemotherapy

• No prior chemotherapy for SCLC

Endocrine therapy

• Not specified

Radiotherapy

• No prior thoracic or neck radiotherapy
• No concurrent intensity-modulated radiotherapy

Surgery

• See Disease Characteristics
• At least 2 weeks since prior thoracic or major surgery and recovered

Other

• No concurrent amifostine