Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- cisplatin
- Conditions
- Lung Cancer
- Sponsor
- Gundersen Lutheran Health System
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: Primary * 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. Secondary * 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.
Investigators
Ronald Go
Hematologist
Gundersen Lutheran Health System
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Oral cyclophosphamide plus standard cisplatin with etoposide
1. Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3 2. Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles 3. Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
Intervention: cisplatin
Oral cyclophosphamide plus standard cisplatin with etoposide
1. Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3 2. Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles 3. Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
Intervention: cyclophosphamide
Oral cyclophosphamide plus standard cisplatin with etoposide
1. Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3 2. Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles 3. Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
Intervention: etoposide
Outcomes
Primary Outcomes
Safety
Time Frame: From time of registration to 30 days post treatment of last cycle.
Effect of metronomic chemotherapy on circulating endothelial cells
Time Frame: Baseline to progression
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.
Secondary Outcomes
- Progression-free survival(Registration to time of progression)
- Response rate(From Registration to time of disease progression)
- Overall survival(From registration to time patient expires)