Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061919
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2003-06-05
Brief Title:
Carboplatin and Etoposide With or Without Thalidomide in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Phase III Randomized Double Blind Placebo Controlled Trial Of CarboplatinEtoposide With Or Without Thalidomide In Small Cell Lung Cancer Study 12
Status:
COMPLETED
Status Verified Date:
2012-03
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 carboplatin and etoposide use different ways to stop tumor cells from dividing so they stop growing or die Thalidomide may stop the growth of cancer by stopping blood flow to the tumor It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating small cell lung cancer
PURPOSE This randomized phase III trial is studying carboplatin etoposide and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer
PURPOSE This randomized phase III trial is studying carboplatin etoposide and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the survival of patients with limited or extensive stage small cell lung cancer treated with carboplatin and etoposide with vs without thalidomide
Compare the time to disease progression in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the response rates of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage limited vs extensive ECOG performance status 0 and 1 vs 2 and alkaline phosphatase no greater than 15 times upper limit of normal ULN vs greater than 15 times ULN Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 1-2 hours on days 1 and 2 and orally on day 3 Patients also receive oral thalidomide daily beginning on day 1
Arm II Patients receive carboplatin and etoposide as in arm I and oral placebo daily beginning on day 1
NOTE Patients who are unable to receive etoposide IV on day 2 may receive oral etoposide on days 2 and 3
In both arms chemotherapy carboplatin and etoposide repeats every 3 weeks for up to 6 courses Patients receive thalidomide or placebo continuously for up to 2 years Treatment continues in the absence of disease progression or unacceptable toxicity Patients who experience disease progression may continue to receive thalidomide or placebo provided the patient is clinically and symptomatically stable
Quality of life is assessed at baseline during each course of chemotherapy at 3-4 weeks after completion of chemotherapy and at 6 12 18 and 24 months
Patients are followed every 2 months for 2 years after the completion of chemotherapy and then every 3 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 372 patients 186 per treatment arm will be accrued for this study
Compare the survival of patients with limited or extensive stage small cell lung cancer treated with carboplatin and etoposide with vs without thalidomide
Compare the time to disease progression in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the response rates of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage limited vs extensive ECOG performance status 0 and 1 vs 2 and alkaline phosphatase no greater than 15 times upper limit of normal ULN vs greater than 15 times ULN Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 1-2 hours on days 1 and 2 and orally on day 3 Patients also receive oral thalidomide daily beginning on day 1
Arm II Patients receive carboplatin and etoposide as in arm I and oral placebo daily beginning on day 1
NOTE Patients who are unable to receive etoposide IV on day 2 may receive oral etoposide on days 2 and 3
In both arms chemotherapy carboplatin and etoposide repeats every 3 weeks for up to 6 courses Patients receive thalidomide or placebo continuously for up to 2 years Treatment continues in the absence of disease progression or unacceptable toxicity Patients who experience disease progression may continue to receive thalidomide or placebo provided the patient is clinically and symptomatically stable
Quality of life is assessed at baseline during each course of chemotherapy at 3-4 weeks after completion of chemotherapy and at 6 12 18 and 24 months
Patients are followed every 2 months for 2 years after the completion of chemotherapy and then every 3 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 372 patients 186 per treatment arm 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 |
|---|---|---|---|
| ISRCTN16174527 | REGISTRY | ISRCTN | None |
| LLCG-STUDY-12 | OTHER | None | None |
| EU-20207 | OTHER | None | None |