Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054548
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2003-02-05
Brief Title:
Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Antisense Bcl-2 Oligonucleotide G3139 in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more sensitive to the drugs
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of G3139 in combination with carboplatin and paclitaxel
II To determine the quantitative and qualitative nature of toxicities of G3139 with carboplatin and paclitaxel
III To measure G3139 activity in peripheral blood lymphocytes by quantitating Bcl-2Bax expression and transcription as well as T-cell functioning and signaling
IV To measure G3139 activity in tumor biopsy specimens by quantitating Bcl-2Bax expression and transcription
V To determine the pharmacokinetics of carboplatin paclitaxel and G3139 as well as intratumoral G3139 levels
VI To screen various signal transduction pathways that may be affected by Bcl-2 down-regulation in PBMC and tumor biopsy specimens in order to better understand the mechanism of G3139 chemosensitization
VII To seek preliminary evidence of antitumor activity for the combination of G3139 carboplatin and paclitaxel
OUTLINE This is a dose-escalation study of oblimersen
Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD
I To determine the maximum tolerated dose MTD of G3139 in combination with carboplatin and paclitaxel
II To determine the quantitative and qualitative nature of toxicities of G3139 with carboplatin and paclitaxel
III To measure G3139 activity in peripheral blood lymphocytes by quantitating Bcl-2Bax expression and transcription as well as T-cell functioning and signaling
IV To measure G3139 activity in tumor biopsy specimens by quantitating Bcl-2Bax expression and transcription
V To determine the pharmacokinetics of carboplatin paclitaxel and G3139 as well as intratumoral G3139 levels
VI To screen various signal transduction pathways that may be affected by Bcl-2 down-regulation in PBMC and tumor biopsy specimens in order to better understand the mechanism of G3139 chemosensitization
VII To seek preliminary evidence of antitumor activity for the combination of G3139 carboplatin and paclitaxel
OUTLINE This is a dose-escalation study of oblimersen
Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD
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 |
|---|---|---|---|
| U01CA062491 | NIH | None | httpsreporternihgovquickSearchU01CA062491 |
| CO 02904 | None | None | None |
| NCI-5912 | None | None | None |
| WCCC-CO-02904 | None | None | None |