Chemotherapy Plus Radiation Therapy in Treating Patients With Squamous Cell Cancer of the Head and Neck
Recruitment status was Active, not recruiting
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||October 1995|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003200 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chemotherapy Plus Radiation Therapy in Treating Patients With Squamous Cell Cancer of the Head and Neck|
|Official Title ICMJE||Taxotere Plus Concurrent Radiotherapy After Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck (TAXT-XRT)|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with squamous cell cancer of the head and neck.
OBJECTIVES: I. Determine the maximum tolerated dose of weekly docetaxel when administered as concurrent therapy with radiation therapy after treatment with induction chemotherapy in patients with squamous cell carcinoma of the head and neck. II. Determine the toxicity profile of this regimen in these patients. III. Obtain preliminary assessment of the efficacy of this regimen in these patients. IV. Study potential predictors of tumor resistance prospectively through tumor biopsies and tissues.
OUTLINE: This is a dose escalation study. Patients are administered 1 hour IV infusions of docetaxel weekly for 6 weeks concurrently with radiation therapy 5 days a week for 6 weeks. Patients are treated in cohorts of 3-5 patients per dose. An entire cohort must complete treatment at a given dose level before a new cohort is accrued at a higher dose. The maximum tolerated dose (MTD) is the dose level below that at which dose limiting toxicity occurs in 2 of 5 patients. At the MTD, 15 additional patients are treated to assess for toxicity. Patients are followed every 3 months until disease progression or death.
PROJECTED ACCRUAL: A maximum of 35 patients is accrued into this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Head and Neck Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||35|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.) Previously untreated Stage III or IV (M0) No exophytic T3 N0 tumors or T1 N1 lesions May be entered after initial induction therapy Evaluable disease Must have received therapy with one of the following induction regimens, except as modified for toxicity: - Cisplatin at least 80 mg/m2/cycle and fluorouracil at least 1000 mg/m2/day for at least 4 days every 4 weeks - Carboplatin at least 300 mg/m2/cycle and fluorouracil at least 1000 mg/m2/day for at least 4 days every 4 weeks - Cisplatin at least 25 mg/m2/day over 5 days, fluorouracil at least 800 mg/m2/day on days 2-5 and leucovorin at least 500 mg/m2/day over 5 days, every 4 weeks
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 4,000/mm3 Absolute neutrophil count normal Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusions permitted, if not used solely for achieving the eligibility criteria) Hepatic: SGOT less than 1.5 times upper limit of normal (ULN) Total bilirubin and SGOT no greater than 2 times ULN as an isolated value Alkaline phosphatase less than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN as an isolated value Renal: Not specified Cardiovascular: No acute cardiac dysrhythmias or unstable cardiac conditions such as angina Neurology: No peripheral neuropathy greater than grade 1 Nutritional status: Adequate and nutritionally balanced enteral intake (at least 1,800 kcal/day) No intravenous alimentation as primary source of calories No weight loss of greater than 20% of body weight in past 3 months Other: No prior allergy to polysorbate 80 No other serious illness or medical condition No persistent diarrhea No other prior or concurrent malignancy, unless disease free for at least 5 years, except: Limited basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Not pregnant or nursing Adequate contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 5 years other than described in Disease Characteristics No greater than 3 cycles of prior chemotherapy as described in Disease Characteristics Endocrine therapy: Prior hormone therapy allowed Radiotherapy: No prior radiotherapy for squamous cell cancer of the head and neck Surgery: May have undergone surgery as the sole treatment for disease 2 or more years prior to study
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003200|
|Other Study ID Numbers ICMJE||CDR0000066044, DFCI-95041, NCI-G98-1382|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Dana-Farber Cancer Institute|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||June 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP