Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00002659
- Lead Sponsor
- Matrix Pharmaceutical
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Ville Marie Oncology Center
π¨π¦Montreal, Quebec, Canada
Palmetto Richland Memorial Hospital
πΊπΈColumbia, South Carolina, United States
Creighton University Cancer Center
πΊπΈOmaha, Nebraska, United States
UCSF Cancer Center and Cancer Research Institute
πΊπΈSan Francisco, California, United States
Sylvester Cancer Center, University of Miami
πΊπΈMiami, Florida, United States
Oregon Cancer Center at Oregon Health Sciences University
πΊπΈPortland, Oregon, United States
Department of Otolaryngology
πΊπΈMilwaukee, Wisconsin, United States
Comprehensive Cancer Center at JFK Medical Center
πΊπΈAtlantis, Florida, United States
Veterans Affairs Medical Center - Tucson
πΊπΈTucson, Arizona, United States
Evanston Northwestern Health Care
πΊπΈEvanston, Illinois, United States
Arizona Cancer Center
πΊπΈTucson, Arizona, United States
Louisiana State University Hospital - Shreveport
πΊπΈShreveport, Louisiana, United States
Jonsson Comprehensive Cancer Center, UCLA
πΊπΈLos Angeles, California, United States
Veterans Affairs Medical Center - Palo Alto
πΊπΈPalo Alto, California, United States
Veterans Affairs Medical Center - Baltimore
πΊπΈBaltimore, Maryland, United States
Methodist Cancer Center - Omaha
πΊπΈOmaha, Nebraska, United States
University of Texas Southwestern Medical School
πΊπΈDallas, Texas, United States
Thompson Cancer Survival Center
πΊπΈKnoxville, Tennessee, United States
University of New Mexico Cancer Research & Treatment Center
πΊπΈAlbuquerque, New Mexico, United States
Capitol Comprehensive Cancer Care Clinic
πΊπΈJefferson City, Missouri, United States
Boston Cancer Group
πΊπΈMemphis, Tennessee, United States
Montreal General Hospital
π¨π¦Montreal, Quebec, Canada
Stanford University Medical Center
πΊπΈStanford, California, United States
University of Kentucky College of Medicine
πΊπΈLexington, Kentucky, United States
Washington University School of Medicine
πΊπΈSaint Louis, Missouri, United States
Louisiana State University Medical Center - New Orleans
πΊπΈNew Orleans, Louisiana, United States
Southwest Regional Cancer Center
πΊπΈAustin, Texas, United States
University of Kansas Medical Center
πΊπΈKansas City, Kansas, United States