Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

• Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC).

Secondary

• Determine the safety of cisplatin and pemetrexed disodium in these patients.
• Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium.

OUTLINE: This is a multicenter study.

• Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor.
• Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• Stage IB, II, IIIA, or IIIB (T4, N0-1) disease

• Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET) scan
• Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results
• If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI
• Measurable and resectable disease

• T4 lesions must be resectable
• Eligible for curative surgery
• No malignant pleural effusion

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,250/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 3.0 times ULN

Renal

• Creatinine clearance ≥ 45 mL/min

Pulmonary

• Adequate pulmonary reserve to undergo surgery

• Predicted FEV_1 > 0.8 L after resection

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Able to take corticosteroids
• Able to take folic acid or vitamin B_12 supplements
• No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer
• No concurrent serious or uncontrolled disorder that would preclude study participation
• No type I diabetes mellitus

• Type II diabetes mellitus allowed if glucose is 80-150 mg/dL

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy
• No concurrent prophylactic filgrastim (G-CSF)
• No concurrent thrombopoiesis-stimulating agents

Chemotherapy

• At least 5 years since prior chemotherapy

Endocrine therapy

• No concurrent anticancer hormonal therapy

Radiotherapy

• No prior radiotherapy to the chest
• No concurrent curative or palliative radiotherapy

Surgery

• Not specified

Other

• At least 30 days since prior non-FDA-approved or investigational agents
• At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents [e.g., piroxicam])
• No other concurrent anticancer therapy
• No other concurrent investigational agents