Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060112
Status:
TERMINATED
Last Update Posted:
2013-01-25
First Post:
2003-05-06
Brief Title:
Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Oblimersen Genasense G3139 in Combination With Gemcitabine in Advanced Malignancies
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy such as gemcitabine use different ways to stop cancer cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of gemcitabine by making cancer cells more sensitive to the drug This phase I trial is studying the side effects and best dose of oblimersen and gemcitabine in treating patients with metastatic or unresectable solid tumors or lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and gemcitabine in patients with advanced solid tumor or lymphoma
II Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of gemcitabine in these patients
III Determine the toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine 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 Up to 10 additional patients receive treatment at the MTD
PROJECTED ACCRUAL Approximately 15 patients will be accrued for this study within 6-8 months
I Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and gemcitabine in patients with advanced solid tumor or lymphoma
II Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of gemcitabine in these patients
III Determine the toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine 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 Up to 10 additional patients receive treatment at the MTD
PROJECTED ACCRUAL Approximately 15 patients will be accrued for this study within 6-8 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 |
|---|---|---|---|
| CDR0000299507 | REGISTRY | PDQ Physician Data Query | None |
| SUMC-78808 | None | None | None |