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Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx Clinical research trials and Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx. Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx  Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
For Condition: stage 4 squamous cell carcinoma of the larynx,stage 3 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the nasopharynx,stage 4A squamous cell carcinoma of the nasopharynx,stage 3 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the lip and oral cavity,stage 3 squamous cell carcinoma of the lip and oral cavity,stage 4B squamous cell carcinoma of the nasopharynx,stage 4 squamous cell carcinoma of the hypopharynx,stage 3 squamous cell carcinoma of the larynx
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of fludarabine that can be given during the sixth and seventh weeks of radiotherapy in patients with locally advanced squamous cell carcinoma of the oral cavity, pharynx, or larynx, based on the systemic toxicity of the drug and the acute mucosal reactions in the irradiated fields. II. Document the qualitative and quantitative toxicity of this combination therapy in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of fludarabine. Patients receive radiotherapy on days 1-5 for 7 weeks. Patients receive fludarabine IV on days 1-5 of weeks 6 and 7 of radiotherapy. Fludarabine is administered 3-4 hours prior to daily radiotherapy. Cohorts of 3 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose that produces a severe toxicity rate nearest to 20%. Patients are followed every 4 weeks after the completion of treatment until acute reactions have resolved, then every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx for which surgery would result in significant functional impairment; Stage III or IV (T3-4 or N2-3) - No distant metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 - Life expectancy: At least 6 months - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 150,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT less than 4 times upper limit of normal; PT/PTT normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other concurrent acute illness or infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
K.Ang, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067492; MDA-ID-95038,NCI-H99-0046
Study Start Date: May 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004246
Other Stage 3 Squamous Cell Carcinoma Of The Larynx Studies:
1. Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
2. High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
3. Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
4. Gene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat
5. Erlotinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Mouth or Throat Cancer
Related Studies:
Other stage 3 squamous cell carcinoma of the larynx Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
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