Back to resultsCisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin-e therapeutic implant
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Medical Center - Palo Alto
- UCSF Cancer Center and Cancer Research Institute
- Stanford University Medical Center
- Comprehensive Cancer Center at JFK Medical Center
- Sylvester Cancer Center, University of Miami
- Evanston Northwestern Health Care
- University of Kansas Medical Center
- University of Kentucky College of Medicine
- Louisiana State University Medical Center - New Orleans
- Louisiana State University Hospital - Shreveport
- Veterans Affairs Medical Center - Baltimore
- Capitol Comprehensive Cancer Care Clinic
- Washington University School of Medicine
- Methodist Cancer Center - Omaha
- Creighton University Cancer Center
- University of New Mexico Cancer Research & Treatment Center
- Oregon Cancer Center at Oregon Health Sciences University
- Palmetto Richland Memorial Hospital
- Thompson Cancer Survival Center
- Boston Cancer Group
- Southwest Regional Cancer Center
- University of Texas Southwestern Medical School
- Department of Otolaryngology
- Montreal General Hospital
- Ville Marie Oncology Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002659
First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
Matrix Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00002659
Brief Title
Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Matrix Pharmaceutical
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cisplatin-e therapeutic implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mack H. Mabry, MD
Organizational Affiliation
SUGEN
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Veterans Affairs Medical Center - Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-0128
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
Comprehensive Cancer Center at JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
University of Kentucky College of Medicine
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Louisiana State University Medical Center - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State University Hospital - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Veterans Affairs Medical Center - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Methodist Cancer Center - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Creighton University Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
University of New Mexico Cancer Research & Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Oregon Cancer Center at Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Palmetto Richland Memorial Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Boston Cancer Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Texas Southwestern Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9032
Country
United States
Facility Name
Department of Otolaryngology
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Ville Marie Oncology Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1L5
Country
Canada
12. IPD Sharing Statement
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Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer
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