Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 dividing. Pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by making tumor cells more sensitive to chemotherapy. It is not yet known whether etoposide and cisplatin or carboplatin are more effective with or without pravastatin in treating small cell lung cancer.

PURPOSE: This randomized phase III trial is studying etoposide and cisplatin or carboplatin to see how well they work when given as first-line chemotherapy together with pravastatin compared with first-line chemotherapy and a placebo in treating patients with small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Carboplatin; Cisplatin; Etoposide; Etoposide phosphate; Pravastatin

Criteria

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