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Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: Fludarabine Phosphate (Drug); Radiation Therapy (RT) (Radiation)

Phase: Phase 1

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
K. Kian Ang, MD, PhD, Study Chair, Affiliation: M.D. Anderson Cancer Center


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.

Clinical Details

Official title: A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) of Fludarabine During Sixth & Seventh Weeks of Radiotherapy

Detailed description: 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. 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Locations and Contacts

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

UT MD Anderson Cancer Center Website

Starting date: May 2000
Last updated: July 27, 2012

Page last updated: August 20, 2015

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