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

NCT00002659 | Unknown Phase 3

• 3 other identifiers: CDR0000064225MP-414-94-2NCI-V95-0676
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 28

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.

Conditions

Head and Neck Cancer

Keywords

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

Interventions

cisplatin-e therapeutic implant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Matrix Pharmaceutical: lead

Study Sites (28)

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, 94304, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Comprehensive Cancer Center at JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

University of Kentucky College of Medicine

Lexington, Kentucky, 40536-0084, United States

Location

Louisiana State University Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Hospital - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, 21218, United States

Location

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, 65109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Methodist Cancer Center - Omaha

Omaha, Nebraska, 68114, United States

Location

Creighton University Cancer Center

Omaha, Nebraska, 68131-2197, United States

Location

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

Palmetto Richland Memorial Hospital

Columbia, South Carolina, 29203, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Boston Cancer Group

Memphis, Tennessee, 38119, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

University of Texas Southwestern Medical School

Dallas, Texas, 75235-9032, United States

Location

Department of Otolaryngology

Milwaukee, Wisconsin, 53226, United States

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Ville Marie Oncology Center

Montreal, Quebec, H3G 1L5, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mack H. Mabry, MD

  SUGEN

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 31, 2004
• Study Start: May 1, 1995
• Last Updated: December 19, 2013

Record last verified: 2007-05

Locations

CA (2); US (26)