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| ID | Type | Description | Link |
|---|---|---|---|
| S9902 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| docetaxel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Wolfram E. Samlowski, MD, BA | University of Utah | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - University of South Alabama | Mobile | Alabama | 36688 | United States | ||
| CCOP - Greater Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17530488 | Result | 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. |
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| Every 6 weeks until progression of disease. |
| Response | 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. |
| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix | Arizona | 85012 | United States |
| Veterans Affairs Medical Center - Tucson | Tucson | Arizona | 85723 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | 72205 | United States |
| Veterans Affairs Medical Center - Long Beach | Long Beach | California | 90822 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033-0800 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Beckman Research Institute, City of Hope | Los Angeles | California | 91010 | United States |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | 94553 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
| Veterans Affairs Medical Center - Denver | Denver | Colorado | 80220 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80262 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | 30905-5650 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | 60141 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | United States |
| Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | 40511-1093 | United States |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | 40536-0084 | United States |
| MBCCOP - LSU Medical Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | 70112 | United States |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | 71130-3932 | United States |
| Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | 71130 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | 02130 | United States |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0752 | United States |
| Veterans Affairs Medical Center - Detroit | Detroit | Michigan | 48201-1932 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| Providence Hospital - Southfield | Southfield | Michigan | 48075-9975 | United States |
| Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | 39531-2410 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | 39216 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | 64128 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| St. Louis University Health Sciences Center | St Louis | Missouri | 63110-0250 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | 87108-5138 | United States |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | United States |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | 45219 | United States |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | 45220-2288 | United States |
| Cleveland Clinic Cancer Center | Cleveland | Ohio | 44195 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Cancer Services | Columbus | Ohio | 43214 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Kettering | Ohio | 45429 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Cancer Center at Oregon Health Sciences University | Portland | Oregon | 97201-3098 | United States |
| Veterans Affairs Medical Center - Portland | Portland | Oregon | 97207 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97213 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-1329 | United States |
| Texas Tech University Health Science Center | Lubbock | Texas | 79423 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284-7811 | United States |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | 78284 | United States |
| Veterans Affairs Medical Center - Temple | Temple | Texas | 76504 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84132 | United States |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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