Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer

  • Previously untreated disease
  • No mixed histology

• Extensive-stage disease

  • Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• No symptomatic, untreated, or uncontrolled CNS metastases

  • CNS metastases previously treated with whole-brain radiotherapy allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR
• Direct bilirubin normal
• ALT and AST ≤ 3 times ULN (5 times ULN if there is liver involvement)

Renal

• Creatinine clearance ≥ 45 mL/min

Cardiovascular

• No angina pectoris
• No congestive heart failure within the past 3 months, unless ejection fraction > 40%
• No cardiac arrhythmia
• No myocardial infarction within the past 3 months
• No hypertension, including labile hypertension

Pulmonary

• No interstitial pneumonia
• No extensive and symptomatic interstitial fibrosis of the lung

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of poor compliance with antihypertensive medication
• Able to take folic acid, cyanocobalamin (vitamin B_12) supplementation, or dexamethasone
• No uncontrolled diabetes
• No serious condition that would preclude study participation
• No clinically significant infection
• No significant traumatic injury

• No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

  • Low-grade (Gleason score ≤ 6), localized prostate cancer allowed even if diagnosed < 5 years prior to study entry
• No seizure disorder
• No other severe and/or uncontrolled medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy
• No concurrent immunomodulating agents

Chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics

• Prior palliative radiotherapy allowed

  • No prior palliative radiotherapy to the chest except for ≤ 3 fractions for superior vena cava syndrome
• No concurrent radiotherapy

Surgery

• More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy
• More than 2 weeks since prior minor surgery* NOTE: *Insertion of a vascular access device is not considered major or minor surgery

Other

• More than 4 weeks since prior investigational therapy
• No concurrent Hypericum perforatum (St. John's wort)
• No concurrent inducers or inhibitors of CYP3A4
• No concurrent medications that are metabolized by CYP3A4
• No aspirin dose ≥ 1.3 grams per day for ≥ 10 days prior to and after study treatment
• No other concurrent cytostatic or cytotoxic agents