|
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical research trials and Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer  Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
For Condition: Head and Neck Cancer
Status: No longer recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RoyTishler, Study Chair, Dana-Farber/Harvard Cancer Center
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000068118; DFCI-99274,NCI-G00-1833
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006107
Other Head And Neck Cancer Studies:
1. Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
2. Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
3. Combination Chemotherapy Plus Amifostine in Treating Patients With Metastatic or Unresectable Cancer
4. Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
5. Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
|
|
|
|
|
|
|
|
