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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Mack H. Mabry, MD
Study Chair
SUGEN
United States: Federal Government
CDR0000064225
NCT00002659
May 1995
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
Methodist Cancer Center - Omaha | Omaha, Nebraska 68114 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
Louisiana State University Medical Center - New Orleans | New Orleans, Louisiana 70112 |
University of New Mexico Cancer Research & Treatment Center | Albuquerque, New Mexico 87131 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
Comprehensive Cancer Center at JFK Medical Center | Atlantis, Florida 33462 |
University of Kentucky College of Medicine | Lexington, Kentucky 40536-0084 |
Louisiana State University Hospital - Shreveport | Shreveport, Louisiana 71130-3932 |
Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
Creighton University Cancer Center | Omaha, Nebraska 68131-2197 |
Palmetto Richland Memorial Hospital | Columbia, South Carolina 29203 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Boston Cancer Group | Memphis, Tennessee 38119 |
Southwest Regional Cancer Center | Austin, Texas 78705 |
University of Texas Southwestern Medical School | Dallas, Texas 75235-9032 |
Department of Otolaryngology | Milwaukee, Wisconsin 53226 |