- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003908
S9902 Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Evaluation of the Combination of Docetaxel (Taxotere)/ Carboplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have metastatic or recurrent head and neck cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Assess the survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck receiving docetaxel and carboplatin. II. Assess time to treatment failure and response rate (unconfirmed and confirmed complete and partial response) in this patient population. III. Evaluate the toxicities of this regimen in this patient population.
OUTLINE: Patients receive docetaxel IV over 1 hour immediately followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually thereafter until death.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study over 18 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36688
- MBCCOP - University of South Alabama
-
-
Arizona
-
Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
-
Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
-
Tucson, Arizona, United States, 85724
- Arizona Cancer Center
-
Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
-
-
California
-
Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
-
Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, United States, 91010
- Beckman Research Institute, City of Hope
-
Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
-
Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
-
Sacramento, California, United States, 95817
- University of California Davis Medical Center
-
Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
-
Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
-
-
Georgia
-
Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
-
Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
-
-
Illinois
-
Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
-
Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
-
Kansas
-
Kansas City, Kansas, United States, 66160-7357
- University of Kansas Medical Center
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
-
-
Kentucky
-
Lexington, Kentucky, United States, 40511-1093
- Veterans Affairs Medical Center - Lexington
-
Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
-
New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
-
Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
-
Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
-
Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
-
Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids Clinical Oncology Program
-
Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
-
-
Mississippi
-
Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
-
Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
-
Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
-
Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
-
-
Missouri
-
Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
-
Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
-
Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
-
-
Montana
-
Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
-
Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
-
-
New York
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Barrett Cancer Center, The University Hospital
-
Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Cancer Center
-
Columbus, Ohio, United States, 43206
- CCOP - Columbus
-
Columbus, Ohio, United States, 43214
- Cancer Services
-
Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
-
Kettering, Ohio, United States, 45429
- CCOP - Dayton
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
-
Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
-
-
Oregon
-
Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
-
Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
-
Texas
-
Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
-
Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
-
Galveston, Texas, United States, 77555-1329
- University of Texas Medical Branch
-
Lubbock, Texas, United States, 79423
- Texas Tech University Health Science Center
-
San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, United States, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
-
Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- Huntsman Cancer Institute
-
Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
-
-
Washington
-
Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
-
Seattle, Washington, United States, 98104
- Swedish Cancer Institute
-
Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
-
Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck Metastatic disease at diagnosis OR Persistent, metastatic or recurrent disease following surgery and/or radiotherapy No newly diagnosed nonmetastatic disease Bidimensionally measurable disease Demonstrated progressive disease if only measurable site is within a previous radiotherapy port
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Calcium no greater than upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or any adequately treated stage I or II cancer that is currently in complete remission No neuropathy sensory greater than grade 1 No history of hypersensitivity reaction to Polysorbate 80
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior carboplatin or cisplatin No prior chemotherapy for recurrent disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except oral contraceptives or treatment for osteoporosis) Radiotherapy: See Disease Characteristics At least 28 days since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 28 days since prior surgery and recovered
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Weekly while on protocol treatment, then every 3 months for 1 year, then every 6 months for 2 years.
|
Overall survival was defined as the duration from the date of registration to the date of death due to any cause.
Patients last known to be alive were censored at the date of last contact.
|
Weekly while on protocol treatment, then every 3 months for 1 year, then every 6 months for 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival
Time Frame: Every 6 weeks until progression of disease.
|
Progression-Free Survival was defined as the duration between the date of registration and the date of first documentation of progression of disease or death due to any cause.
Progression of disease was defined as a 50% increase in the sum of products of perpendicular diameters of measurable lesions or an increase of at least 10 square centimeters, whichever was smaller, or clear worsening of non-measurable lesions in the opinion of the treating investigator, appearance of new lesions, reappearance of lesions that had previously disappeared, or symptomatic deterioration.
|
Every 6 weeks until progression of disease.
|
Response
Time Frame: Every 6 weeks while on protocol treatment.
|
Response was defined as a confirmed or unconfirmed complete or partial response.
A complete response (CR) was defined as disappearance of all disease.
A partial response (PR) was defined as a 50% decrease or greater in the sum of perpendicular diameters of all measurable lesions.
A CR or PR was defined as confirmed if there were two consecutive determinations at least 3 weeks apart.
|
Every 6 weeks while on protocol treatment.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Wolfram E. Samlowski, MD, BA, University of Utah
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage IV squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067086
- U10CA032102 (U.S. NIH Grant/Contract)
- S9902 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on carboplatin
-
Eisai Inc.CompletedCancerUnited States, Austria, India
-
Samyang Biopharmaceuticals CorporationCompleted
-
NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
-
Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
-
National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
-
National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
-
MEI Pharma, Inc.CompletedPeritoneal Neoplasms | Ovarian Cancer | Fallopian Tube CancerUnited States, Spain, Belgium, United Kingdom, Australia, Italy, Poland
-
Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCCompletedTesticular Germ Cell TumorUnited Kingdom, Canada, Norway, Netherlands, South Africa, Brazil, Finland
-
AkesoRecruitingAdvanced Squamous Non Small Cell Lung CancerChina