S9902 Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

NCT00003908 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000067086S9902U10CA032102
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 85

Brief Summary

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.

Conditions

Head and Neck Cancer

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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 Outcomes (2)

• Progression-Free Survival

  Every 6 weeks until progression of disease.

• Response

  Every 6 weeks while on protocol treatment.

Interventions

carboplatin DRUG

docetaxel DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (85)

MBCCOP - University of South Alabama

Mobile, Alabama, 36688, United States

Location

CCOP - Greater Phoenix

Phoenix, Arizona, 85006-2726, United States

Location

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock (McClellan)

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Beckman Research Institute, City of Hope

Los Angeles, California, 91010, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40511-1093, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71130, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, 02130, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Providence Hospital - Southfield

Southfield, Michigan, 48075-9975, United States

Location

Veterans Affairs Medical Center - Biloxi

Biloxi, Mississippi, 39531-2410, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Cancer Services

Columbus, Ohio, 43214, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-1329, United States

Location

Texas Tech University Health Science Center

Lubbock, Texas, 79423, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78284, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Related Publications (1)

• Samlowski WE, Moon J, Kuebler JP, Nichols CR, Gandara DR, Ozer H, Williamson SK, Atkins JN, Schuller DE, Ensley JF. Evaluation of the combination of docetaxel/carboplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN): a Southwest Oncology Group Phase II study. Cancer Invest. 2007 Apr-May;25(3):182-8. doi: 10.1080/07357900701209061.

  PMID: 17530488 RESULT

MeSH Terms

Conditions

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

Interventions

Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Wolfram E. Samlowski, MD, BA

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 21, 2004
• Study Start: November 1, 1999
• Primary Completion: June 1, 2004
• Study Completion: January 1, 2007
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

US (85)