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