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Head and Neck NeoplasmPhase 1NCT00001442

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

A Phase 1 study testing paclitaxel concurrent with radiation therapy in people with Head and Neck Neoplasm and Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
paclitaxel concurrent with radiation therapy
How many people
35 participants
Where
1 siteUnited States
Study dates
Jul 1995to Jun 2004
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Cancer Institute (NCI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read the 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.

Being tested
paclitaxel concurrent with radiation therapy
Keywords
Taxol, Squamous Cell Carcinoma, Radiosensitizer, Radiotherapy, Tumor Potential Doubling Time (Tpot)
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paclitaxel concurrent with radiation therapyDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 1999 (estimated)
  2. Study startJul 1995
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
35 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001442
Sponsor's protocol ID
950162
Other IDs
95-C-0162
Status last verified
Jun 2004
First submitted
3 Nov 1999
Last updated
4 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 2419292

  • 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.

    PubMed 3047335

  • 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.

    PubMed 2442323

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing paclitaxel concurrent with radiation therapy in people with Head and Neck Neoplasm and Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001442, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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