Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042978
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2002-08-05
Brief Title:
Carboplatin and Etoposide With or Without Oblimersen Sodium in Treating Patients With Extensive Stage Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study Of Carboplatin And Etoposide With Or Without G3139 NSC 683428 IND 58842 In Patients With Extensive Stage Small Cell 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:
This phase II trial studies how well carboplatin and etoposide with or without oblimersen sodium works in treating patients with extensive stage small cell lung cancer Drugs used in chemotherapy such as carboplatin and etoposide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Biological therapies such as oblimersen sodium may stimulate the immune system in different ways and stop cancer cells from growing Giving carboplatin and etoposide together with oblimersen sodium may kill not tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To assess the percentage of patients with extensive stage small cell lung cancer treated with G3139 oblimersen sodium carboplatin and etoposide who live longer than 12 months
SECONDARY OBJECTIVES
I To assess the response rate of patients treated with G3139 carboplatin and etoposide
II To assess the toxicity of the combination of G3139 carboplatin and etoposide
III To compare the toxicity observed to that seen in a cohort of patients treated with carboplatin and etoposide alone
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oblimersen sodium intravenously IV continuously on days 1-8 carboplatin IV over 30 minutes on day 6 and etoposide IV over 60 minutes on days 6-8 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year and then every 6 months for 2 years
I To assess the percentage of patients with extensive stage small cell lung cancer treated with G3139 oblimersen sodium carboplatin and etoposide who live longer than 12 months
SECONDARY OBJECTIVES
I To assess the response rate of patients treated with G3139 carboplatin and etoposide
II To assess the toxicity of the combination of G3139 carboplatin and etoposide
III To compare the toxicity observed to that seen in a cohort of patients treated with carboplatin and etoposide alone
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oblimersen sodium intravenously IV continuously on days 1-8 carboplatin IV over 30 minutes on day 6 and etoposide IV over 60 minutes on days 6-8 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year and then every 6 months for 2 years
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB 30103 | None | None | None |