Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer|
- Safety [ Time Frame: From time of registration to 30 days post treatment of last cycle. ] [ Designated as safety issue: Yes ]
- Effect of metronomic chemotherapy on circulating endothelial cells [ Time Frame: Baseline to progression ] [ Designated as safety issue: No ]Collected cycle 1/day 1 of chemotherapy, Cycle 1/day 8, cycle 1/day 22, and then day 85 and 141, and at disease progression.
- Progression-free survival [ Time Frame: Registration to time of progression ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: From Registration to time of disease progression ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From registration to time patient expires ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Oral cyclophosphamide plus standard cisplatin with etoposide
60 mg/m2 IV day 1, every 21 days for 4 cycles.Drug: cyclophosphamide
25 mg by mouth BID days 8-19 or each cycle x 4 cycles. After restaging (if no progression) maintenance cyclophosphamide alone 25 mg by mouth BID daily until disease progression
Other Name: CytoxanDrug: etoposide
120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3
Other Name: VP-16
- Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with extensive stage small cell lung cancer.
- Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients.
- Determine progression-free survival, tumor response rate, and overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 30 minutes-2 hours on day 1, etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily on days 2-3, and oral cyclophosphamide twice daily on days 8-19. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Maintenance therapy: Patients receive oral cyclophosphamide twice daily in the absence of disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083161
|United States, Wisconsin|
|Gundersen Lutheran Center for Cancer and Blood|
|La Crosse, Wisconsin, United States, 54601|
|Study Chair:||Ronald S. Go, MD||Gundersen Lutheran Center for Cancer and Blood|