Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055822
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2003-03-06
Brief Title:
Combination Chemotherapy and Oblimersen in Treating Patients With Advanced 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 Study of Oblimersen Sodium G3139 Genasense in Combination With Oxaliplatin 5FU and Leucovorin FOLFOX4 Regimen in Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 Combining more than one drug may kill more tumor cells Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs
PURPOSE Phase III trial to study the effectiveness of combining oxaliplatin fluorouracil and leucovorin with oblimersen in treating patients who have unresectable metastatic or recurrent colorectal cancer
PURPOSE Phase III trial to study the effectiveness of combining oxaliplatin fluorouracil and leucovorin with oblimersen in treating patients who have unresectable metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of oblimersen when administered with oxaliplatin fluorouracil and leucovorin calcium in patients with advanced colorectal cancer
Determine the quantitative and qualitative toxic effects of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
Determine the plasma pharmacokinetics of oblimersen and oxaliplatin in patients treated with this regimen
Determine relevant predictive biomarkers of response in patients treated with this regimen
OUTLINE This is an open-label phase I dose-escalation study of oblimersen followed by a non-randomized phase II study
Phase I Patients receive oblimersen IV continuously on days 1-5 and 15-19 leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 6 7 20 and 21 and oxaliplatin IV over 2 hours on days 6 and 20
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
Phase II Up to 35 additional patients are treated as in phase I with oblimersen at the MTD
In both phases courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 6-53 patients 6-18 patients for phase I and 12-35 patients for phase II will be accrued for this study
Determine the maximum tolerated dose of oblimersen when administered with oxaliplatin fluorouracil and leucovorin calcium in patients with advanced colorectal cancer
Determine the quantitative and qualitative toxic effects of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
Determine the plasma pharmacokinetics of oblimersen and oxaliplatin in patients treated with this regimen
Determine relevant predictive biomarkers of response in patients treated with this regimen
OUTLINE This is an open-label phase I dose-escalation study of oblimersen followed by a non-randomized phase II study
Phase I Patients receive oblimersen IV continuously on days 1-5 and 15-19 leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 6 7 20 and 21 and oxaliplatin IV over 2 hours on days 6 and 20
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
Phase II Up to 35 additional patients are treated as in phase I with oblimersen at the MTD
In both phases courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 6-53 patients 6-18 patients for phase I and 12-35 patients 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 |
|---|---|---|---|
| NCI-5793 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |
| U01CA069853 | NIH | None | None |
| P30CA054174 | NIH | None | None |
| SACI-IDD-02-23 | OTHER | None | None |