Status:
COMPLETED
Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer
Lead Sponsor:
University College, London
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
Detailed Description
OBJECTIVES: Primary * Compare the survival of patients with small cell lung cancer treated with etoposide phosphate in combination with cisplatin or carboplatin as first-line chemotherapy with vs wi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Limited stage or extensive stage disease
- No mixed cell histology
- No symptomatic brain metastases that require immediate radiotherapy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy \> 8 weeks
- Platelet count \> 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count \> 1,500/mm\^3
- Glomerular filtration rate ≥ 50 mL/min
- Creatine kinase ≤ 5 times upper limit of normal (ULN)
- Liver function tests (ALP, ALT/AST, and bilirubin) \< 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 1 year after completion of chemotherapy/radiotherapy and for an additional 28 days after completion of pravastatin sodium
- Able to tolerate chemotherapy
- No evidence of significant medical condition or laboratory finding that, in the opinion of the investigator, would preclude study participation
- No family history of hypercholesterolemia
- No history of malignant tumor unless the patient has been without evidence of disease for ≥ 3 years or tumor was a nonmelanoma skin tumor or early cervical cancer
- PRIOR CONCURRENT THERAPY:
- More than 12 months since prior statin
- More than 4 weeks since prior fibrates (e.g., bezofibrate, gemfibrozil, or fenofibrate)
- No prior chemotherapy for this cancer
- No prior radiotherapy for this cancer unless to distant metastases (i.e., not within the thorax or thoracic/cervical spine area)
- No concurrent cyclosporine
- Concurrent radiotherapy allowed
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
846 Patients enrolled
Trial Details
Trial ID
NCT00433498
Start Date
January 1 2007
End Date
November 1 2013
Last Update
December 3 2014
Active Locations (86)
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1
William Harvey Hospital
Ashford-Kent, England, United Kingdom, TN24 0LZ
2
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
3
North Devon District Hospital
Barnstaple, England, United Kingdom, EX31 4JB
4
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG