Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047229
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2002-10-03
Brief Title:
Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma Liver Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study of G3139 in Combination With Doxorubicin in Advanced Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-11
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 such as doxorubicin use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of combining oblimersen with doxorubicin in treating patients who have locally advanced recurrent or metastatic hepatocellular carcinoma liver cancer
PURPOSE Phase II trial to study the effectiveness of combining oblimersen with doxorubicin in treating patients who have locally advanced recurrent or metastatic hepatocellular carcinoma liver cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of oblimersen and doxorubicin in patients with advanced hepatocellular carcinoma or other incurable solid tumor closed to accrual as of 11703 Phase I completed as of 11604
Determine the efficacy of this regimen in terms of objective response rate in these patients
Determine the toxicity of this regimen in these patients
Determine the time to progression response duration progression-free survival median survival and overall survival rates in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study Phase I completed as of 11604
Patients receive oblimersen IV continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5 Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen and doxorubicin 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 Once the MTD is determined additional patients including 6 patients with hepatocellular carcinoma HCC are treated at the recommended phase II dose Phase I completed as of 11604
NOTE Other solid tumors closed to accrual as of 11703 only accruing HCC patients
PROJECTED ACCRUAL A total of 12-18 patients will be accrued for the phase I portion of this study within 6 months phase I completed as of 11604 A total of 30 patients will be accrued for the phase II portion of this study within 10-15 months
Determine the maximum tolerated dose of oblimersen and doxorubicin in patients with advanced hepatocellular carcinoma or other incurable solid tumor closed to accrual as of 11703 Phase I completed as of 11604
Determine the efficacy of this regimen in terms of objective response rate in these patients
Determine the toxicity of this regimen in these patients
Determine the time to progression response duration progression-free survival median survival and overall survival rates in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study Phase I completed as of 11604
Patients receive oblimersen IV continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5 Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen and doxorubicin 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 Once the MTD is determined additional patients including 6 patients with hepatocellular carcinoma HCC are treated at the recommended phase II dose Phase I completed as of 11604
NOTE Other solid tumors closed to accrual as of 11703 only accruing HCC patients
PROJECTED ACCRUAL A total of 12-18 patients will be accrued for the phase I portion of this study within 6 months phase I completed as of 11604 A total of 30 patients will be accrued for the phase II portion of this study within 10-15 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 |
|---|---|---|---|
| NCI-5798 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000257565 | REGISTRY | None | None |