Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004173
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
1999-12-10
Brief Title:
Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Oxaliplatin in Combination With Paclitaxel
Status:
UNKNOWN
Status Verified Date:
2003-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 paclitaxel in treating patients who have metastatic or unresectable cancer
PURPOSE Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer
Determine the qualitative and quantitative toxicities of this regimen in these patients
Determine the therapeutic response to this regimen in these patients
Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients
Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics toxicity and response in these patients
OUTLINE This is a dose escalation study
Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel 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 Approximately 20 patients will be accrued for this study within 12-18 months
Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer
Determine the qualitative and quantitative toxicities of this regimen in these patients
Determine the therapeutic response to this regimen in these patients
Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients
Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics toxicity and response in these patients
OUTLINE This is a dose escalation study
Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel 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 Approximately 20 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0017 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067419 | REGISTRY | None | None |