NCT00001442

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 1995

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

June 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Head and Neck NeoplasmSquamous Cell Carcinoma

Keywords

TaxolSquamous Cell CarcinomaRadiosensitizerRadiotherapyTumor Potential Doubling Time (Tpot)

Interventions

paclitaxel concurrent with radiation therapyDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Kun LE, Toohill RJ, Holoye PY, Duncavage JA, Byhardt RW, Ritch PS, Grossman TW, Hoffmann RG, Cox JD, Malin T. A randomized study of adjuvant chemotherapy for cancer of the upper aerodigestive tract. Int J Radiat Oncol Biol Phys. 1986 Feb;12(2):173-8. doi: 10.1016/0360-3016(86)90090-8.

    PMID: 2419292BACKGROUND

  • Rossi A, Molinari R, Boracchi P, Del Vecchio M, Marubini E, Nava M, Morandi L, Zucali R, Pilotti S, Grandi C, et al. Adjuvant chemotherapy with vincristine, cyclophosphamide, and doxorubicin after radiotherapy in local-regional nasopharyngeal cancer: results of a 4-year multicenter randomized study. J Clin Oncol. 1988 Sep;6(9):1401-10. doi: 10.1200/JCO.1988.6.9.1401.

    PMID: 3047335BACKGROUND

  • Fu KK, Phillips TL, Silverberg IJ, Jacobs C, Goffinet DR, Chun C, Friedman MA, Kohler M, McWhirter K, Carter SK. Combined radiotherapy and chemotherapy with bleomycin and methotrexate for advanced inoperable head and neck cancer: update of a Northern California Oncology Group randomized trial. J Clin Oncol. 1987 Sep;5(9):1410-8. doi: 10.1200/JCO.1987.5.9.1410.

    PMID: 2442323BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1995

Study Completion

June 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-06

Locations

US(1)