Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck
- 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
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
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
Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
6 weeks after last chemotherapy treatment
Barbara A. Murphy, MD
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC HN 0164
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Center for Biomedical Research||Knoxville, Tennessee 37909|
|Jackson-Madison County Hospital||Jackson, Tennessee 38301|
|Meharry Medical College||Nashville, Tennessee 37208-3599|
|Erlanger Health System||Chattanooga, Tennessee 37403|
|East Tennessee State University||Johnson City, Tennessee 37614-0054|
|Central Georgia Hematology Oncology Associates, P.C.||Macon, Georgia|
|VA Tennessee Valley Healthcare Center||Nashville, Tennessee|