Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433498
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2007-02-08
Brief Title:
Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer
Sponsor:
University College London
Organization:
University College London
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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
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 phosphate 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
Some patients may undergo blood and urine sample collection 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
PROJECTED ACCRUAL A total of 842 patients will be accrued for this study
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 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
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 phosphate 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
Some patients may undergo blood and urine sample collection 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
PROJECTED ACCRUAL A total of 842 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTAAC-C1312-A12462 | None | None | None |
| CRUK-LUNGSTAR | None | None | None |
| EU-20649 | None | None | None |
| ISRCTN56306957 | None | None | None |
| EUDRACT-2005-005821-71 | None | None | None |
| UCL-BRD05129 | None | None | None |
| MREC-06-MRE10-28 | None | None | None |
| CTA-20363-0215-001 | None | None | None |
| CTAAC-C1312-A5335 | None | None | None |