Spots Global Cancer Trial Database for Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer
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Trial Identification
Brief Title: Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer
Official Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATIN/EPINEPHRINE INJECTABLE GEL (PRODUCT MPI 5010) WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Study ID: NCT00002659
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer.
Detailed Description: OBJECTIVES: I. Compare the effect of intratumoral injection of a cisplatin/epinephrine gel (CDDP-e TI) to placebo gel for local control of recurrent or refractory squamous cell carcinoma of the head and neck. II. Assess achievement of a preselected (by the investigator) treatment goal for the most troublesome tumor in patients with recurrent or refractory squamous cell carcinoma of the head and neck following up to 6 weekly intratumoral treatments with CDDP-e TI vs. placebo gel. III. Compare the effect of CDDP-e TI to placebo gel on total local tumor volume per patient. IV. Evaluate the time to response and time to progression for the most troublesome tumor after local treatment with CDDP-e TI vs. placebo gel. V. Assess the improvement in or stabilization of quality of life in these patients as measured by the FACT-H\&N questionnaire. VI. Compare the histopathology of injected lesions that respond to local treatment. OUTLINE: Randomized, double-blind study. Randomization weighted 2:1 in favor of Arm I. Arm I: Intratumoral Chemotherapy. Cisplatin (NSC-119875) and Epinephrine in a bovine collagen gel, MP 5010, CDDP-e TI. Arm II: Control. NS in a bovine collagen gel, PLCB. PROJECTED ACCRUAL: Up to 120 evaluable patients will be studied to provide 80 evaluable patients on Arm I and 40 evaluable patients on Arm II.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Stanford University Medical Center, Stanford, California, United States
Comprehensive Cancer Center at JFK Medical Center, Atlantis, Florida, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Evanston Northwestern Health Care, Evanston, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Kentucky College of Medicine, Lexington, Kentucky, United States
Louisiana State University Medical Center - New Orleans, New Orleans, Louisiana, United States
Louisiana State University Hospital - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
Capitol Comprehensive Cancer Care Clinic, Jefferson City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Methodist Cancer Center - Omaha, Omaha, Nebraska, United States
Creighton University Cancer Center, Omaha, Nebraska, United States
University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico, United States
Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon, United States
Palmetto Richland Memorial Hospital, Columbia, South Carolina, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Boston Cancer Group, Memphis, Tennessee, United States
Southwest Regional Cancer Center, Austin, Texas, United States
University of Texas Southwestern Medical School, Dallas, Texas, United States
Department of Otolaryngology, Milwaukee, Wisconsin, United States
Montreal General Hospital, Montreal, Quebec, Canada
Ville Marie Oncology Center, Montreal, Quebec, Canada
Contact Details
Name: Mack H. Mabry, MD
Affiliation: SUGEN
Role: STUDY_CHAIR
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