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About
The purpose of this research study is to develop a new chemo radiotherapy regimen for the treatment of cancer of the head and neck for patients who have received induction chemotherapy; and to determine the highest dose of Taxotere which can be safely given together with radiotherapy.
Full description
In this investigational research study investigators are attempting to develop a new chemo radiotherapy regimen in which radiotherapy and Taxotere will be combined after having received induction chemotherapy. Taxotere has never been given together with radiotherapy, the highest dose of Taxotere that can be safely used in this setting in unknown. Taxotere will be added to radiotherapy gradually as each subsequent group of 3-5 patients gets a larger dose. Taxotere doses will be increased until certain toxicities occur. This will help investigators determine the best way to combine Taxotere with radiotherapy and to use that knowledge to treat other patients with tumors like yours.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Pathology: Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc)
Stage: Patients can be entered on this protocol after initial induction therapy, if prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. This excludes patients with exophytic T3N0 tumors or T1N1 lesions at the onset of induction therapy. Evaluable disease during induction therapy is required.
--Required Prior therapy: Patients entered on this protocol must have received therapy with one of the following induction regimens, except as modified for toxicity:
Other Malignancies:
Other Prior Therapy: Patients who were previously treated with radiotherapy for SCCHN are not eligible. Patients treated with any form of prior chemotherapy , other than induction therapy described in section 3.21 within the last 5 years are not eligible. Hormonally treated patients are eligible.
Performance: Patients must meet the following performance criteria:
Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows:
Allergies: Patients with prior allergy to polysorbate 80 (see appendix) are ineligible
Informed Consent: Patients must give written informed consent
Follow-up: All patients must be available for monthly evaluation and restaging by the head and neck cancer clinic on therapy
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22 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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