A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD) of Fludarabine During Sixth & Seventh Weeks of Radiotherapy
Outcome Description:
MTD based on systemic toxicity of drug and acute mucosal reactions in the irradiated fields.
Outcome Time Frame:
Every 4 weeks
Safety Issue:
Yes
Principal Investigator
K. Kian Ang, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
ID95-038
NCT ID:
NCT00004246
Start Date:
May 2000
Completion Date:
December 2002
Related Keywords:
- Head and Neck Cancer
- Radiation Therapy
- RT
- Radiotherapy
- Fludarabine
- Fludara
- Fludarabine Phosphate
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Mouth Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
