Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004243
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2000-01-28
Brief Title:
Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
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 Docetaxel Taxotere MetastaticRecurrent Solid Tumors
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 docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor
PURPOSE Phase I trial to study the effectiveness of docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of docetaxel when followed by oxaliplatin in patients with metastatic or recurrent solid tumors II Describe the toxicities of this regimen in this patient population at each dose level studied III Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients
OUTLINE This is a dose escalation study of docetaxel Patients receive docetaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks Treatment continues in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed for disease progression
PROJECTED ACCRUAL A total of 15-20 patients will be accrued for this study within 2 years
OUTLINE This is a dose escalation study of docetaxel Patients receive docetaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks Treatment continues in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed for disease progression
PROJECTED ACCRUAL A total of 15-20 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-T99-0004 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062505 |
| U01CA062505 | NIH | None | None |
| CHNMC-PHASEI-24 | None | None | None |
| CHNMC-IRB-99081 | None | None | None |
| LAC-USC-OC-99-2 | None | None | None |