A Pilot Study of Paclitaxel With Radiation Therapy for Locally Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001442
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: June 2004
  Purpose

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.


Condition Intervention Phase
Head and Neck Neoplasm
Squamous Cell Carcinoma
Drug: paclitaxel concurrent with radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Pilot Study of Paclitaxel With Radiation Therapy for Locally Advanced Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 35
Study Start Date: July 1995
Estimated Study Completion Date: June 2004
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 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001442

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001442     History of Changes
Other Study ID Numbers: 950162, 95-C-0162
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Taxol
Squamous Cell Carcinoma
Radiosensitizer
Radiotherapy
Tumor Potential Doubling Time (Tpot)

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014