Pemetrexed Disodium and Carboplatin in Treating Patients With 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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer|
- Proportion of confirmed-tumor response [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- Determine the complete and partial response rates in patients with previously untreated, extensive-stage small cell lung cancer treated with pemetrexed disodium and carboplatin.
- Determine the toxicity of this regimen in these patients.
- Determine, preliminarily, the survival of patients treated with this regimen.
- Determine, preliminarily, the response rate in patients 70 years and older treated with this regimen.
- Determine, preliminarily, the toxicity of this regimen in patients 70 years and older.
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.
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|Study Chair:||James R. Jett, MD||Mayo Clinic|
|Investigator:||Albert M. Bernath, MD||Geisinger Cancer Institute at Geisinger Health|
|Investigator:||Julian Molina, MD, PhD||Mayo Clinic|