Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-30 @ 10:14 PM
Study NCT ID:
NCT00005035
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2000-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
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:
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?: