Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001442
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Pilot Study of Paclitaxel With Radiation Therapy for Locally Advanced Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Paclitaxel With Radiation Therapy for Locally Advanced Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2004-06
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:
Radiotherapy plus Single-Agent ChemotherapyRadiosensitization Irradiation of tumor and involved nodes using 4-6 MV photons brachytherapy allowed to boost primary tumor electrons allowed to boost posterior neck and massive adenopathy plus Paclitaxel Bristol-Myers Taxol TAX NSC-125973
Detailed Description:
This is a pilot study designed to evaluate the toxicity of a five day infusion of Paclitaxel concurrent with radiation therapy for advanced head and neck cancers Patients with previously untreated Stage III and IV squamous cell cancer SCC of the oral cavity oropharynx hypopharynx nasopharynx larynx and maxillary sinus as well as Stage II SCC of the base of the tongue nasopharynx and maxillary sinus will be eligible Radiation therapy will be delivered at 180 cGy per day to a total dose 6660-7200 cGy Individual neck nodes can be boosted with electrons up to 7600 cGy Patients will also receive Paclitaxel as a continuous IV infusion of 120 mgm2 over 120 hours through a central venous catheter Tolerance of this regimen will be judged by using the RTOG and CTEP standard toxicity criteria and by following the median elapsed treatment time Serial tumor biopsies will be obtained to measure the following parameters tumor potential doubling time Tpot paclitaxel levels in tumor and biological effects upon the cell cycle
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 |
|---|---|---|---|
| 95-C-0162 | None | None | None |