A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Corey J. Langer, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Community Medical Center||Toms River, New Jersey 08755|
|St. Francis Medical Center||Trenton, New Jersey 08629|
|Delaware County Memorial Hospital||Drexel Hill, Pennsylvania 19026|
|Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|South Jersey Regional Cancer Center||Millville, New Jersey 08332|
|Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County||Mount Holly, New Jersey 08060|
|Hunterdon Regional Cancer Center||Flemington, New Jersey 08822|
|Kimball Medical Center||Lakewood, New Jersey 08701|
|Riverview Medical Center - Booker Cancer Center||Red Bank, New Jersey 07701|
|Saint Mary Regional Center||Langhorne, Pennsylvania 19047|
|Paoli Memorial Hospital||Paoli, Pennsylvania 19301-1792|
|Pinnacle Health Hospitals||Harrisburg, Pennsylvania 17105-8700|
|Conemaugh Memorial Hospital||Johnstown, Pennsylvania 15905|
|Pottstown Memorial Regional Cancer Center||Pottstown, Pennsylvania 19464|
|Bon Secours-Holy Family Health System||Altoona, Pennsylvania 16602|
|Central Montgomery Medical Center||Lansdale, Pennsylvania 19446-1200|