Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057863
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2003-04-07
Brief Title:
Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in treating patients who have locally recurrent or metastatic cervical cancer 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
Detailed Description:
PRIMARY OBJECTIVES
I To determine the objective response rates for the combination of paclitaxel and oxaliplatin in patients with metastatic or locally recurrent cervical cancer
II To determine the toxicities and recovery from toxicities of patients with cervical cancer receiving paclitaxel and oxaliplatin
OUTLINE
Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed ever 3 months
I To determine the objective response rates for the combination of paclitaxel and oxaliplatin in patients with metastatic or locally recurrent cervical cancer
II To determine the toxicities and recovery from toxicities of patients with cervical cancer receiving paclitaxel and oxaliplatin
OUTLINE
Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed ever 3 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 |
|---|---|---|---|
| P30CA013330 | NIH | CTEP | httpsreporternihgovquickSearchP30CA013330 |
| NCI-2012-03004 | REGISTRY | None | None |
| NCI-5840 | None | None | None |
| 0902-492 | OTHER | None | None |
| 5840 | OTHER | None | None |
| N01CM62204 | NIH | None | None |