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Spots Global Cancer Trial Database for Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Barbara A. Murphy, MD

Affiliation: Vanderbilt-Ingram Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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