Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2018 |
| Start Date: | June 7, 1995 |
| End Date: | December 2, 2002 |
A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
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.
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.
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.
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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