Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Treatments||docetaxel, conventional surgery, radiation therapy|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2000|
|Trial identifier||NCT00006107, CDR0000068118, DFCI-99274, NCI-G00-1833|
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|
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
|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.|
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