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Phase III Randomized Study of Etoposide in Combination With Cisplatin or Carboplatin as First-Line Chemotherapy With Versus Without Pravastatin in Patients With Small Cell Lung Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Biomarker/Laboratory analysis, Treatment | Active | 18 and over | CRUK-LUNGSTAR EU-20649, ISRCTN56306957, EUDRACT-2005-005821-71, UCL-BRD/05/129, NCT00433498 |
Objectives Primary - Compare the survival of patients with small cell lung cancer treated with etoposide in combination with cisplatin or carboplatin as first-line chemotherapy with vs without pravastatin.
Secondary - Compare the progression-free survival of patients treated with these regimens.
- Compare the local progression-free survival (local control) of these patients.
- Compare the response rate in these patients.
- Compare the toxicity of these regimens in these patients.
Entry Criteria Disease Characteristics:
- Histologically or cytologically confirmed small cell lung cancer
- Limited stage or extensive stage disease
- No symptomatic brain metastases that require immediate radiotherapy
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
Patient Characteristics:
- ECOG performance status 0-3
- Life expectancy > 8 weeks
- Platelet count > 100,000/mm3
- Hemoglobin > 10.0 g/dL
- Absolute neutrophil count > 1,500/mm3
- Glomerular filtration rate ≥ 50 mL/min
- Creatine kinase ≤ 5 times upper limit of normal (ULN)
- Liver function tests < 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 study treatment
- 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
Expected Enrollment 1300A total of 1,300 patients will be accrued for this study. Outcomes Primary Outcome(s)Survival
Secondary Outcome(s)Progression-free survival Local progression-free survival (local control) Response rate as measured by RECIST criteria after course 3 Toxicity as measured by CTCAE version 3.0
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. - Arm I: Patients receive oral pravastatin daily beginning on day 1 of chemotherapy and continuing for up to 24 months.
- Arm II: Patients receive oral placebo daily beginning on day 1 of chemotherapy and continuing for up to 24 months.
Blood and urine samples are collected at baseline and periodically during and after study treatment. Samples are examined by genetic analysis, metabonomics and proteomics (to detect expression of RAS proteins, phospho-Erk, and other signals downstream of RAS), and cholesterol measurements. 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.
Trial Contact Information
Trial Lead Organizations University College Hospital - London | | | Michael Seckl, MD, PhD, Protocol chair | | | | Trial Sites
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United Kingdom |
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England |
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London |
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| | | | Charing Cross Hospital |
| | Michael Seckl, MD, PhD | |
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Newport |
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| | St. Mary's Hospital |
| | Christopher Baughan, MD | |
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Southampton |
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| | Southampton General Hospital |
| | Christian Ottensmeier, MD, PhD | |
| Email:
cho@soton.ac.uk |
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Registry Information | | 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 | | Trial Start Date | | 2006-10-01 | | Registered in ClinicalTrials.gov | | NCT00433498 | | Date Submitted to PDQ | | 2007-01-16 | | Information Last Verified | | 2007-02-26 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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