Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017251
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-06-06
Brief Title:
Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Genasense A Bcl-2 Antisense Oligonucleotide Combined With Carboplatin And Etoposide In Patients With 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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may make tumor cells more sensitive to chemotherapy drugs Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer
II Determine the toxicity and feasibility of this regimen in these patients III Determine potential antitumor activity of this regimen as assessed by objective response in these patients
OUTLINE This is a multicenter dose-escalation study of oblimersen G3139
Patients receive G3139 IV continuously on days 1-8 carboplatin IV over 30 minutes on day 6 and etoposide IV over 1 hour on days 6-8 Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 6-12 patients will be accrued for this study within 5 months
I Determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer
II Determine the toxicity and feasibility of this regimen in these patients III Determine potential antitumor activity of this regimen as assessed by objective response in these patients
OUTLINE This is a multicenter dose-escalation study of oblimersen G3139
Patients receive G3139 IV continuously on days 1-8 carboplatin IV over 30 minutes on day 6 and etoposide IV over 1 hour on days 6-8 Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 6-12 patients will be accrued for this study within 5 months
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 |
|---|---|---|---|
| CDR0000068667 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17102 |
| 10992A | None | None | None |
| N01CM17102 | NIH | None | None |