Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002659
• Other study ID #: CDR0000064225
• Secondary ID: MP-414-94-2NCI-V
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: May 1995

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck that is recurrent or refractory following at least 1 course of therapy Primary or metastatic tumors involving skin, nodes (palpable and biopsy- proven), subcutaneous tissue, or muscle allowed No involvement of major artery or any visceral organ Measurable lesions accessible for direct intratumoral injection with no immediate risk of hemorrhage or embolization Most troublesome tumor (identified by the investigator) at least 0.5 cc and no greater than 20 cc Smaller tumors eligible for treatment but not for efficacy assessment An improvable primary treatment goal (palliative or preventive) for most troublesome tumor must be identified by the investigator prior to enrollment If multiple tumors qualify as most troublesome and share the primary physician-selected treatment goal, the largest tumor is selected Patient may also select a most troublesome tumor and 1 palliative treatment goal for that tumor (need not match the physician-selected tumor or goal) No fibrotic lesions (e.g., previously irradiated lesion with no subsequent disease progression) No tumors involving or threatening to invade the carotid or other major vessel

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Life expectancy: At least 6 months Hematopoietic: Absolute granulocyte count greater than 1,000/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No NYHA class III/IV status No history of arrhythmia that would increase risk of treatment Other: No hypersensitivity to cisplatin, bovine collagen, epinephrine, or sulfites No significant history of extracranial carotid vascular disease from atherosclerosis, radiation therapy or previous carotid artery surgery No uncontrolled local infection at treatment sites No medical or psychiatric condition that would preclude informed consent No pregnant or nursing women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: More than 28 days since any antineoplastic therapy or therapy with investigational agents Fully recovered from side effects of prior treatment

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin-e therapeutic implant

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Ville Marie Oncology Center	Montreal	Quebec
United States	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico
United States	Comprehensive Cancer Center at JFK Medical Center	Atlantis	Florida
United States	Southwest Regional Cancer Center	Austin	Texas
United States	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland
United States	Palmetto Richland Memorial Hospital	Columbia	South Carolina
United States	University of Texas Southwestern Medical School	Dallas	Texas
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Capitol Comprehensive Cancer Care Clinic	Jefferson City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	University of Kentucky College of Medicine	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Boston Cancer Group	Memphis	Tennessee
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Department of Otolaryngology	Milwaukee	Wisconsin
United States	Louisiana State University Medical Center - New Orleans	New Orleans	Louisiana
United States	Creighton University Cancer Center	Omaha	Nebraska
United States	Methodist Cancer Center - Omaha	Omaha	Nebraska
United States	Veterans Affairs Medical Center - Palo Alto	Palo Alto	California
United States	Oregon Cancer Center at Oregon Health Sciences University	Portland	Oregon
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Louisiana State University Hospital - Shreveport	Shreveport	Louisiana
United States	Stanford University Medical Center	Stanford	California
United States	Arizona Cancer Center	Tucson	Arizona
United States	Veterans Affairs Medical Center - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Matrix Pharmaceutical

Countries where clinical trial is conducted

United States,  Canada,