Status:
COMPLETED
Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Gundersen Lutheran Health System
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 circulatin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00083161
Start Date
June 1 2003
End Date
May 1 2010
Last Update
September 5 2012
Active Locations (1)
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1
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601