Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	GLO-03-06-06 NCT00083161

Objectives

Primary

1. Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with extensive stage small cell lung cancer.
2. Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients.

Secondary

1. Determine progression-free survival, tumor response rate, and overall survival in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed small cell lung cancer
  • Extensive stage disease (i.e., disease beyond the hemithorax and cannot be encompassed safely by a tolerable radiation field)



• Measurable disease



• Concurrent CNS metastases allowed provided patient remains asymptomatic
  • Radiotherapy or surgery for uncontrolled symptoms allowed before study entry

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Concurrent corticosteroids for brain metastases allowed

Radiotherapy

• See Disease Characteristics
• Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not previously irradiated
• No concurrent radiotherapy

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8 g/dL (transfusion allowed)

Hepatic

• ALT ≤ 2 times upper limit of normal (ULN)
• Bilirubin ≤ 2 times ULN

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance ≥ 60 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past year except adequately treated basal cell or squamous cell skin cancer

Expected Enrollment

A total of 10 patients will be accrued for this study.

Outcomes

Safety
Effect of metronomic chemotherapy on circulating endothelial cells

Progression-free survival
Response rate
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

Gundersen Lutheran Center for Cancer and Blood

Ronald Go, MD, Protocol chair		Ph: 608-775-2139; 800-362-9567 ext. 52385

U.S.A.
Wisconsin
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org

Registry Information
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
Trial Start Date		2003-06-25
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00083161
Date Submitted to PDQ		2004-03-25
Information Last Verified		2008-11-30

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