Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
- Registration Number
- NCT00022711
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Temozolomide temozolomide Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Kimball Medical Center
🇺🇸Lakewood, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Hunterdon Regional Cancer Center
🇺🇸Flemington, New Jersey, United States
Riverview Medical Center - Booker Cancer Center
🇺🇸Red Bank, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Bon Secours-Holy Family Health System
🇺🇸Altoona, Pennsylvania, United States
Pinnacle Health Hospitals
🇺🇸Harrisburg, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Conemaugh Memorial Hospital
🇺🇸Johnstown, Pennsylvania, United States
Central Montgomery Medical Center
🇺🇸Lansdale, Pennsylvania, United States
Saint Mary Regional Center
🇺🇸Langhorne, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center
🇺🇸Pottstown, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States