Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003103
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase IIIA Dose-Escalating Trial of BCL-2 Antisense G3139 Treatment for Patients With Androgen-Independent Prostate Cancer or Other Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2013-07
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of oblimersen in treating patients who have solid tumors that have not responded to previous therapy
PURPOSE Phase III trial to study the effectiveness of oblimersen in treating patients who have solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Evaluate the safety and plasma concentration profiles of oblimersen G3139 administered alone or in combination with docetaxel in patients with advanced solid tumors expressing the bcl-2 oncogene II Determine the plasma concentration profiles maximum tolerated dose MTD andor optimal biologic dose OBD of this treatment regimen in these patients III Determine the antitumor effects of G3139 at the MTD or OBD in combination with docetaxel in patients with androgen-independent refractory or recurrent prostate cancer
OUTLINE This is a dose-escalation study of oblimersen G3139 Phase I Patients receive G3139 IV on days 1-5 and docetaxel IV on day 5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity 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 at which no more than 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Phase II Patients receive G3139 continuously over 21 days at one dose level below the MTD in combination with weekly docetaxel Patients receive up to 2 more courses of therapy in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A maximum of 57 patients 42 for phase I and 15 for phase II will be accrued for this study
OUTLINE This is a dose-escalation study of oblimersen G3139 Phase I Patients receive G3139 IV on days 1-5 and docetaxel IV on day 5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity 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 at which no more than 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Phase II Patients receive G3139 continuously over 21 days at one dose level below the MTD in combination with weekly docetaxel Patients receive up to 2 more courses of therapy in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A maximum of 57 patients 42 for phase I and 15 for phase II 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 |
|---|---|---|---|
| CDR0000065836 | REGISTRY | None | None |
| GENTA-G3139-9701 | None | None | None |
| NCI-G97-1337 | Registry Identifier | PDQ Physician Data Query | None |