|
A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer Clinical research trials and A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer. A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer clinical trial. Subjects typically recieve the finest healthcare available for their A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer  A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer
A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer
For Condition: Head and Neck Neoplasm,Squamous Cell Carcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. 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.
Details: 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 mg/m(2) 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.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Patients must satisfy the following criteria: The patient must have a biopsy proven diagnosis of carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, maxillary sinus. Squamous cell, lymphoepithelioma, transitional cell and undifferentiated histologies will be included. We will accept AJCC stages III-IV for all the sites, except base of tongue, nasopharynx, and maxillary sinus where we will accept stage II patients as well. Patients must have no surgical option or have refused surgery. Patients with evidence of distant metastasis not confined to the region of the head and neck will be excluded. All patients will be evaluated by either the NIH or National Naval Medical Center (NNMC) Otolaryngology-head and neck surgery center. Patients must have had no prior radiotherapy to the head and neck region and no prior treatment with chemotherapy for their head and neck cancers. Patients must have a performance status of less then or equal to 2 (ECOG Criteria). Patients must have an absolute granulocyte count of greater than or equal to 2000/mm(3) and a platelet count of greater than or equal to 100,000/mm(3). Patients should have adequate hepatic and renal function as indicated by a serum bilirubin of less than or equal to 2.0 mg/dl and SGOT of less than or equal to 4.0 times the upper limit of the institutional norm and a serum creatinine of less than or equal to 1.5 mg/dl. No other serious concurrent medical or psychiatric illness which would jeopardize the ability of the patient to receive with reasonable safety the chemotherapy and radiation therapy outlined in this protocol is allowed. No other active, concomitant malignancy other than curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin is allowed. Patients must be at least 18 years old. Signed informed consent: Each patient must be aware of the neoplastic nature of his/her disease and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. Pregnant women and nursing mothers are ineligible. Eligible patients of childbearing potential should use contraception. Patients will be registered on the protocol by telephone. An authorized physician will telephone information concerning a potential candidate for this protocol to the Orkand personnel in their Central Clinical Data Management Registration Office at (301) 402-1732 between the hours of 8:30 am to 5:00 pm Monday through Friday.
Total Enrollment: 35
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950162; 95-C-0162
Study Start Date: July 20, 1995
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001442
Other Squamous Cell Carcinoma Studies:
1. Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer
2. A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer
3. The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
4. Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
5. Recombinant Fowlpox Virus Vaccine to Treat Mouth and Throat Cancer
Related Studies:
Other Squamous Cell Carcinoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Pilot Study of Paclitaxel with Radiation Therapy for Locally Advanced Head and Neck Cancer
|
|
|
|
|
|
|
|
