Head and Neck Cancer Clinical Trial
Official title:
Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating
recurrent or metastatic head and neck cancer.
OBJECTIVES:
- Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with
local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck.
- Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients.
- Determine the palliative effect of irinotecan hydrochloride and cisplatin on head and
neck cancer symptoms using the Vanderbilt Cancer Center (VICC) Head and Neck Cancer
Symptom Survey.
OUTLINE: Patients receive irinotecan hydrochloride IV over 60 minutes and cisplatin IV on
days 1, 8, 22, and 29. Treatment repeats every 6 weeks for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
Patients complete the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey at
baseline, before each course, at the completion of study therapy, and then at each follow-up
visit.
After completion of study therapy, patients are followed every 6 weeks for 1 year and then
every 3 months thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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