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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Starting dose 30 mg/m2 Dose level -1 20 mg/m2
50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.
Central Georgia Hematology Oncology Associates, P.C.
Macon, Georgia, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Jackson-Madison County Hospital
Jackson, Tennessee, United States
East Tennessee State University
Johnson City, Tennessee, United States
Patient Response
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.
Time frame: 6 weeks after last chemotherapy treatment
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death
Time frame: 6 weeks after last chemotherapy
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Center for Biomedical Research
Knoxville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States