Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 70 years vs ≥ 70 years).
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: Approximately 77 patients at least 46 who are < 70 years of age and at least 24 who are ≥ 70 years of age) will be accrued for this study within 20-26 months.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Extensive-stage disease
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
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
No seizure disorder
No other severe and/or uncontrolled medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
See Disease Characteristics
Prior palliative radiotherapy allowed
No concurrent radiotherapy
Surgery
Other
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