Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004870
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2000-03-07
Brief Title:
Olimersen and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase III Pharmacokinetic and Biologic Correlative Study of G3139 NSC 683428 Phosphorothioate Antisense Oligonucleotide Directed to Bcl-2 and Irinotecan in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 Gene therapy such as oblimersen may make tumor cells more sensitive to chemotherapy drugs Combining irinotecan and oblimersen may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining oblimersen and irinotecan in treating patients who have metastatic or recurrent colorectal cancer
PURPOSE Phase III trial to study the effectiveness of combining oblimersen and irinotecan in treating patients who have metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES I Determine the dose-limiting toxic effects and maximum tolerated dose of augmerosen G3139 administered in combination with irinotecan in patients with unresectable metastatic or recurrent colorectal cancer II Determine the quantitative and qualitative toxicity of this drug combination in this patient population III Assess the plasma pharmacokinetics of this combination in these patients IV Document the antitumor activity of this drug combination in these patients in a phase II study V Determine the relevant biologic endpoints of treatment in tumor biopsies prior to and after therapy with G3139 at two dose levels and assess the pharmacokinetic and pharmacodynamic correlations
OUTLINE This is a dose-escalation multicenter study Patients receive augmerosen G3139 IV continuously on days 1-7 and irinotecan IV over 90 minutes on day 6 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of G3139 and irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with G3139 and irinotecan at the recommended phase II dose Patients are followed every 30 days until toxicity resolves
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for the phase I portion of this study A maximum of 55 patients will be accrued for the phase II portion of this study
OUTLINE This is a dose-escalation multicenter study Patients receive augmerosen G3139 IV continuously on days 1-7 and irinotecan IV over 90 minutes on day 6 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of G3139 and irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with G3139 and irinotecan at the recommended phase II dose Patients are followed every 30 days until toxicity resolves
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for the phase I portion of this study A maximum of 55 patients will be accrued for the phase II portion of 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 |
|---|---|---|---|
| NCI-T98-0094 | None | None | None |
| SACI-IDD-98-32 | None | None | None |
| UTHSC-IDD-98-32 | None | None | None |