Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments docetaxel, conventional surgery, radiation therapy
Phase phase 1
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date March 2000
Trial identifier NCT00006107, CDR0000068118, DFCI-99274, NCI-G00-1833

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its variants (e.g., lymphoepithelioma or undifferentiated epidermoid carcinoma) - Stage III or IV (M0) disease - Must have had prior platinum/fluorouracil based initial induction chemotherapy (may have included a taxane) - Previously untreated disease prior to induction regimen - Received 1-3 courses of chemotherapy and less than 7 weeks from the beginning of the last course of induction therapy - Evaluable disease during induction therapy required - No prior head and neck carcinoma except if treated with surgery as sole modality at least 2 years prior to study PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Greater than 3 months Hematopoietic: - WBC at least 3,000/mm^3 OR - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: - SGOT less than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase less than 2.5 times ULN - Bilirubin normal - SGOT no greater than 2 times ULN Renal: - Not specified Cardiovascular: - No acute cardiac dysrhythmias or unstable cardiac condition (e.g., angina) Other: - No other concurrent malignancy within the past 3 years except curatively treated limited basal or squamous cell skin cancer or carcinoma in situ of the cervix - Adequate and nutritionally balanced enteral intake (at least 1,800 kcal/day) - No persistent diarrhea - No peripheral neuropathy of any etiology greater than grade 2 - No other serious illness or medical condition - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 5 years since any other form of prior chemotherapy Endocrine therapy: - Prior hormonal therapy allowed Radiotherapy: - No prior radiotherapy for SCCHN Surgery: - See Disease Characteristics - Percutaneous endoscopic gastrostomy required prior to radiotherapy Other: - No IV alimentation as primary source of calories - Completely recovered from prior diagnostic or therapeutic procedures

Additional Information

Official title Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
Description OBJECTIVES: - Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy. - Determine the toxicity of this treatment regimen in this patient population. - Determine the efficacy of this treatment regimen in these patients. OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks. Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy. Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD. Patients are followed monthly for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).