Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer - NCT00083161-54601(Clinical Trial 121034)
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Lung Cancer |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States
Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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