Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004220
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2000-01-28
Brief Title:
Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase I Study of Oxaliplatin in Combination With Gemcitabine
Status:
COMPLETED
Status Verified Date:
2010-01
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
PURPOSE Phase I trial to study the effectiveness of oxaliplatin and gemcitabine in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of oxaliplatin and gemcitabine in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicities of gemcitabine in combination with oxaliplatin in patients with advanced malignancies II Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients
OUTLINE This is a multicenter dose escalation study of gemcitabine Patients receive oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with a fixed dose of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity
PROJECTED ACCRUAL A total of 24-36 patients will be accrued for this study within 2 years
OUTLINE This is a multicenter dose escalation study of gemcitabine Patients receive oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with a fixed dose of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity
PROJECTED ACCRUAL A total of 24-36 patients will be accrued for this study within 2 years
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-T99-0003 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-PHI-23 | None | None | None |
| CHNMC-PHL-23 | None | None | None |