The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Official Title: Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck
Study ID: NCT00639769
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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
Name: Barbara A. Murphy, MD
Affiliation: Vanderbilt-Ingram Cancer Center
Role: STUDY_CHAIR