A Phase II Activity And Safety Study Of IntraDose (Cisplatin/Epinephrine Injectable Gel) When Given In Combination With Systematic Chemotherapy Paclitaxel And Carboplatin In The Treatment Of Patients With Squamous Cell Carcinoma Of The Head And Neck At First Relapse
OBJECTIVES: I. Determine the antitumor activity of intratumoral cisplatin-epinephrine
injectable gel and systemic paclitaxel and carboplatin in patients with recurrent squamous
cell carcinoma of the head and neck. II. Determine the safety of this regimen in this
patient population. III. Determine the time to progression, pattern of progression, and rate
of relapse of patients treated with this regimen. VI. Determine the time to response and
duration of response of patients treated with this regimen. V. Determine the overall
survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive cisplatin-epinephrine gel
intratumorally on days -15, -8, 1, 8, 15, and 22 for course 1 and days 1, 8, 15, and 22 for
all subsequent courses. Patients also receive paclitaxel IV over at least 3 hours followed
by carboplatin IV over at least 30 minutes on day 1. Treatment repeats every 28 days in the
absence of disease progression or unacceptable toxicity. Patients who achieve local complete
response (CR) and no metastatic disease progression continue treatment with carboplatin and
paclitaxel only. Patients who achieve total CR may receive 2 additional courses of
carboplatin and paclitaxel. Patients are followed at 1-4 weeks and then every 3 months
thereafter.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Laurence Elias, MD
Study Chair
Matrix Pharmaceutical
United States: Federal Government
CDR0000068796
NCT00022217
November 2000
Name | Location |
---|---|
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
Division of Head and Neck Surgery | Evanston, Illinois 60201 |