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

NCT ID: NCT00002659

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-05-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Keywords

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recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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cisplatin-e therapeutic implant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matrix Pharmaceutical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Mack H. Mabry, MD

Role: STUDY_CHAIR

SUGEN

Locations

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Veterans Affairs Medical Center - Tucson

Tucson, Arizona, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, United States

Site Status

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

Comprehensive Cancer Center at JFK Medical Center

Atlantis, Florida, United States

Site Status

Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Site Status

Evanston Northwestern Health Care

Evanston, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kentucky College of Medicine

Lexington, Kentucky, United States

Site Status

Louisiana State University Medical Center - New Orleans

New Orleans, Louisiana, United States

Site Status

Louisiana State University Hospital - Shreveport

Shreveport, Louisiana, United States

Site Status

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, United States

Site Status

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Methodist Cancer Center - Omaha

Omaha, Nebraska, United States

Site Status

Creighton University Cancer Center

Omaha, Nebraska, United States

Site Status

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, United States

Site Status

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Palmetto Richland Memorial Hospital

Columbia, South Carolina, United States

Site Status

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Site Status

Boston Cancer Group

Memphis, Tennessee, United States

Site Status

Southwest Regional Cancer Center

Austin, Texas, United States

Site Status

University of Texas Southwestern Medical School

Dallas, Texas, United States

Site Status

Department of Otolaryngology

Milwaukee, Wisconsin, United States

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Ville Marie Oncology Center

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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MP-414-94-2

Identifier Type: -

Identifier Source: secondary_id

NCI-V95-0676

Identifier Type: -

Identifier Source: secondary_id

CDR0000064225

Identifier Type: -

Identifier Source: org_study_id