Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005035
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2000-04-06
Brief Title:
Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2002-02
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
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating patients who have advanced head and neck cancer
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating patients who have advanced head and neck cancer
Detailed Description:
OBJECTIVES I Determine the response rate of patients with advanced squamous cell carcinoma of the head and neck when treated with oxaliplatin II Characterize the toxicities and pharmacokinetics of this drug in this patient population III Determine the duration of response time to progression and survival of these patients receiving this drug
OUTLINE Patients are stratified according to prior treatment with neoadjuvant chemotherapy yes vs no Patients receive oxaliplatin IV over 2 hours weekly for 4 weeks followed by 2 weeks of rest Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression Patients are followed until toxicity resolves or for no less than 30 days
PROJECTED ACCRUAL A total of 34-74 patients will be accrued for this study within 17 months
OUTLINE Patients are stratified according to prior treatment with neoadjuvant chemotherapy yes vs no Patients receive oxaliplatin IV over 2 hours weekly for 4 weeks followed by 2 weeks of rest Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression Patients are followed until toxicity resolves or for no less than 30 days
PROJECTED ACCRUAL A total of 34-74 patients will be accrued for this study within 17 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 |
|---|---|---|---|
| NCI-T99-0016 | None | None | None |
| OSU-99H0309 | None | None | None |