Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Drugs used in chemotherapy such as pemetrexed disodium, cisplatin, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether pemetrexed disodium is more effective when combined with cisplatin or carboplatin in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of pemetrexed disodium and cisplatin with that of pemetrexed disodium and carboplatin in treating patients who have extensive-stage small cell lung cancer.


Study summary:

OBJECTIVES: - Determine the antitumor activity of pemetrexed disodium and cisplatin or pemetrexed disodium and carboplatin, as measured by the complete and partial tumor response rate, in patients with extensive stage small cell lung cancer. - Determine the duration of response in patients treated with these regimens. - Determine the time to progression in patients treated with these regimens. - Determine the survival time in patients treated with these regimens. - Determine the quantitative and qualitative toxic effects of these regimens in these patients. OUTLINE: This is an open-label, randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive pemetrexed disodium IV over 8-15 minutes and cisplatin IV over 1 hour on day 1. - Arm II: Patients receive pemetrexed disodium as in arm I and carboplatin IV over 1 hour on day 1. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 6 months, and then every 12 weeks for 12 months. PROJECTED ACCRUAL: A total of 34-72 patients (17-36 per treatment arm) will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer (SCLC) - Extensive stage, including malignant pleural effusion - Measurable disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques or 10 mm by spiral CT scan* - Chest x-rays are acceptable if the lesions are clearly defined and surrounded by aerated lung - Clinically detected lesions must be superficial (e.g., skin nodules or palpable lymph nodes) to be considered measurable - Skin lesions are to be documented by color photography, including a ruler to estimate the size of the lesion NOTE: *A solitary measurable lesion must be histologically or cytologically confirmed - No symptomatic brain metastases - No clinically relevant third-space fluid collections (e.g., ascites or pleural effusions) by physical examination that cannot be controlled by drainage or other procedures PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil 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 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 3.0 times ULN* - Alkaline phosphatase no greater than 3.0 times ULN* NOTE: *5 times ULN if liver has tumor involvement Renal - Creatinine clearance at least 45 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study treatment - Able and willing to take folic acid, cobalamin (vitamin B_12), or dexamethasone - Able to tolerate interruption of aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam) - No second primary malignancy except the following: - Carcinoma in situ of the cervix - Adequately treated nonmelanoma skin cancer - Prior low-grade (Gleason score no greater than 6) localized prostate cancer - Other previously treated malignancy with no evidence of recurrence within the past 5 years - No active infection - No other serious concurrent systemic disorder that would preclude patient safety or study completion PRIOR CONCURRENT THERAPY: Biologic therapy - No prior systemic biologic therapy for SCLC - No prior systemic immunotherapy for SCLC - No concurrent prophylactic filgrastim (G-CSF) - No concurrent thrombopoiesis stimulators - No concurrent immunotherapy Chemotherapy - No prior systemic chemotherapy for small cell lung cancer - No prior pemetrexed disodium - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal cancer therapy Radiotherapy - No prior radiotherapy - No concurrent radiotherapy Surgery - No concurrent anticancer surgery Other - More than 30 days since prior investigational drugs - No prior enrollment on this study - No other concurrent experimental medications (except thymidine) - No other concurrent anticancer therapy


NCT ID:

NCT00062088


Primary Contact:

Principal Investigator
Diane Prager, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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