Trial Information

A Phase II Study of Induction Chemotherapy Followed by Concomitant Paclitaxel (1 Hour Infusion), Fluorouracil, Hydroxyurea and Hyperfractionated Radiotherapy for Advanced Oral, Pharynx and Larynx Cancer

OBJECTIVES:

- Evaluate the activity of induction chemotherapy with carboplatin and paclitaxel
followed by concurrent fluorouracil, hydroxyurea, paclitaxel, and hyperfractionated
radiotherapy in terms of response rate, pattern of failure, time to progression, and
overall survival in patients with previously untreated advanced oral, pharyngeal, or
laryngeal cancer.

- Assess this treatment regimen in terms of the pattern and degree of clinical acute,
cumulative, and chronic toxic effects in this patient population.

- Assess the rate of organ preservation in resectable patients treated with this regimen.

- Evaluate the quality of life, organ function, and incidence of second primary tumors in
patients treated with this regimen.

- Assess the rate of complications with subcutaneously implanted IV infusion catheters in
patients treated with this regimen.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes weekly for 3 weeks. Treatment repeats every 4
weeks for 2 courses.

At 1-2 weeks after completion of induction chemotherapy, patients receive oral hydroxyurea
every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, radiotherapy twice
daily on days 1-5, and paclitaxel IV over 1 hour on day 2. Treatment repeats every 2 weeks
for 5 courses.

Patients with residual nodal disease or initially staged nodal disease in the absence of
macroscopic residual disease undergo neck dissection after completion of chemoradiotherapy.
Patients with residual disease at the primary site undergo complete excision of disease.
Patients with disease progression or disease recurrence are considered for conventional
surgical management.

Quality of life is assessed every 3 months for 6 months, every 6 months for 1.5 years, and
then annually thereafter.

Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months
thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 12-18
months.