Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide

• Registration Number: NCT00083161
• Lead Sponsor: Gundersen Lutheran Health System

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2004-05-14
• Study First Submitted QC: 2004-05-14
• Study First Posted: 2004-05-17
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-01
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral cyclophosphamide plus standard cisplatin with etoposide	cisplatin	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
Oral cyclophosphamide plus standard cisplatin with etoposide	cyclophosphamide	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
Oral cyclophosphamide plus standard cisplatin with etoposide	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

Primary Outcome Measures

Name	Time	Method
Safety	From time of registration to 30 days post treatment of last cycle.
Effect of metronomic chemotherapy on circulating endothelial cells	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gundersen Lutheran Center for Cancer and Blood; 🇺🇸 La Crosse, Wisconsin, United States