Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 4:31 PM
Study NCT ID:
NCT00003908
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9902 Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
Evaluation of the Combination of Docetaxel (Taxotere)/ Carboplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Status:
COMPLETED
Status Verified Date:
2013-04
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 docetaxel plus carboplatin in treating patients who have metastatic or recurrent head and neck cancer.
PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have metastatic or recurrent head and neck cancer.
Detailed Description:
OBJECTIVES: I. Assess the survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck receiving docetaxel and carboplatin. II. Assess time to treatment failure and response rate (unconfirmed and confirmed complete and partial response) in this patient population. III. Evaluate the toxicities of this regimen in this patient population.
OUTLINE: Patients receive docetaxel IV over 1 hour immediately followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually thereafter until death.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study over 18 months.
OUTLINE: Patients receive docetaxel IV over 1 hour immediately followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually thereafter until death.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study over 18 months.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S9902 | OTHER | SWOG | View | |
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |