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Sponsored by: |
University College London Hospitals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00433498 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: etoposide Drug: pravastatin Genetic: gene expression analysis Genetic: protein expression analysis Other: laboratory biomarker analysis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Multicentre Phase III Randomized Double Blind Placebo Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Patients With Small Lung Cancer |
Estimated Enrollment: | 1300 |
Study Start Date: | October 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (limited stage vs extensive stage), ECOG performance status (0 or 1 vs 2 or 3), and participating site. Patients are randomized to 1 of 2 treatment arms.
All patients receive chemotherapy comprising cisplatin IV or carboplatin IV on day 1 and etoposide IV on days 1-3 or orally twice daily on days 2 and 3. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for 1 year and every 3 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Charing Cross Hospital | Recruiting |
London, England, United Kingdom, W6 8RF | |
Contact: Michael J. Seckl, MD, PhD 44-20-8846-1421 | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Christian Ottensmeier, MD, PhD 44-23-8079-6184 cho@soton.ac.uk | |
St. Mary's Hospital | Recruiting |
Newport, England, United Kingdom, PO30 5TG | |
Contact: Christopher Baughan, MD 44-1983-524-081 |
Study Chair: | Michael J. Seckl, MD, PhD | Charing Cross Hospital |
Study ID Numbers: | CDR0000531141, CRUK-LUNGSTAR, EU-20649, ISRCTN56306957, EUDRACT-2005-005821-71, UCL-BRD/05/129 |
Study First Received: | February 8, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00433498 History of Changes |
Health Authority: | Unspecified |
extensive stage small cell lung cancer limited stage small cell lung cancer |
Antimetabolites Thoracic Neoplasms Carcinoma, Neuroendocrine Antilipemic Agents Anticholesteremic Agents Carboplatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Pravastatin |
Neuroectodermal Tumors Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Etoposide Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Pravastatin Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Etoposide |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Carboplatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases |