Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have relapsed or progressive small cell lung cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer|
|Study Start Date:||January 2002|
|Study Completion Date:||January 2004|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months
150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months
- Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer.
- Determine the time to progression and overall survival in patients treated with this drug.
- Assess quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy).
Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter.
Patients are followed at 30 days and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022711
|United States, New Jersey|
|Hunterdon Regional Cancer Center|
|Flemington, New Jersey, United States, 08822|
|Kimball Medical Center|
|Lakewood, New Jersey, United States, 08701|
|South Jersey Regional Cancer Center|
|Millville, New Jersey, United States, 08332|
|Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County|
|Mount Holly, New Jersey, United States, 08060|
|Riverview Medical Center - Booker Cancer Center|
|Red Bank, New Jersey, United States, 07701|
|Community Medical Center|
|Toms River, New Jersey, United States, 08755|
|St. Francis Medical Center|
|Trenton, New Jersey, United States, 08629|
|United States, Pennsylvania|
|Bon Secours-Holy Family Health System|
|Altoona, Pennsylvania, United States, 16602|
|Delaware County Memorial Hospital|
|Drexel Hill, Pennsylvania, United States, 19026-1186|
|Pinnacle Health Hospitals|
|Harrisburg, Pennsylvania, United States, 17105-8700|
|Conemaugh Memorial Hospital|
|Johnstown, Pennsylvania, United States, 15905|
|Saint Mary Regional Center|
|Langhorne, Pennsylvania, United States, 19047|
|Central Montgomery Medical Center|
|Lansdale, Pennsylvania, United States, 19446-1200|
|Paoli Memorial Hospital|
|Paoli, Pennsylvania, United States, 19301-1792|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Pottstown Memorial Regional Cancer Center|
|Pottstown, Pennsylvania, United States, 19464|
|Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|Study Chair:||Corey J. Langer, MD||Fox Chase Cancer Center|