Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Information source: Gundersen Lutheran Health System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: cisplatin (Drug); cyclophosphamide (Drug); etoposide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Gundersen Lutheran Health System Official(s) and/or principal investigator(s): Ronald S. Go, MD, Study Chair, Affiliation: Gundersen Lutheran Center for Cancer and Blood
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.
Clinical Details
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
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: SafetyEffect of metronomic chemotherapy on circulating endothelial cells
Secondary outcome: Progression-free survivalResponse rate Overall survival
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin 54601, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2003
Last updated: September 1, 2012
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