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Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about 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 dedicated 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 happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties 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 volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, 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. Human subjects often get the best healthcare available for their Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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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. Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
2. Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
3. Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
4. Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
5. Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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
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