Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
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.
Inclusion 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- 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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Outcome Time Frame:
From time of registration to 30 days post treatment of last cycle.
Safety Issue:
Yes
Principal Investigator
Ronald S. Go, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Gundersen Lutheran Center for Cancer and Blood
Authority:
United States: Federal Government
Study ID:
CDR0000363799
NCT ID:
NCT00083161
Start Date:
June 2003
Completion Date:
May 2010
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
