Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:March 2001
End Date:June 2010

Use our guide to learn which trials are right for you!

Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor
cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in
treating patients who have undergone surgery for stage III or stage IV head and neck cancer.

OBJECTIVES:

- Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with
concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of
high-risk stage III or IV squamous cell carcinoma of the head and neck.

- Determine the disease-free and overall survival of patients treated with this regimen.

- Determine the acute and chronic toxicity of this regimen in these patients.

- Determine the patterns of failure in patients treated with this regimen.

OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical
resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on
approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5
weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3
hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

DISEASE CHARACTERISTICS:

- Histologically proven stage III or IV squamous cell carcinoma of the oral cavity,
oropharynx, larynx, or hypopharynx

- Gross total resection completed or planned

- No less than gross total resection

- No disease requiring staging surgery

- Prior gross total resection completed with one or more of the following risk factors:

- Histologically proven multiple lymph node metastases

- At least 1 lymph node with extracapsular extension of tumor

- Positive margin(s) of resection, including mucosal margins and/or soft tissue or
deep margins of resection OR

- Gross total resection planned within 14 days of study enrollment with anticipated
need for postoperative radiotherapy for one of the following:

- Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm

- Single clinically/radiologically evident lymph node of at least 3 cm

- Histologically proven lymph node metastases

- No T3, N0 glottic cancer

- No nasopharyngeal or paranasal sinus carcinoma

- No distant metastases

PATIENT CHARACTERISTICS:

Age:

- 21 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- White blood cell (WBC) at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than
1.5 times ULN

Renal:

- Creatinine no greater than 1.5 ULN

Cardiovascular:

- No unstable angina

- No myocardial infarction within the past 6 months unless successfully treated with
coronary artery bypass graft or percutaneous transluminal coronary angioplasty

- No uncontrolled arrhythmia

- No second or third degree heart block or other clinically significant conduction
system abnormality unless pacemaker is in place

Pulmonary:

- No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations
within the past year

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No pre-existing grade 2 or greater peripheral neurotoxicity

- No other prior malignancy within the past 3 years except low-risk nonmelanomatous
skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low
to moderate grade prostate cancer

- No significant wound infection

- No fistula

- No major wound dehiscence

- Nutritional status adequate

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Concurrent colony-stimulating factors for neutropenic fever during study
chemoradiotherapy allowed

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to head and neck

Surgery:

- See Disease Characteristics
We found this trial at
216
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
1444
mi
from
Boston, MA
Click here to add this to my saved trials
Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
1149
mi
from
Baltimore, MD
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
1057
mi
from
Buffalo, NY
Click here to add this to my saved trials
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
898
mi
from
Cleveland, OH
Click here to add this to my saved trials
4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
841
mi
from
Detroit, MI
Click here to add this to my saved trials
1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
1152
mi
from
Duarte, CA
Click here to add this to my saved trials
1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
826
mi
from
Flint, MI
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
607
mi
from
Galveston, TX
Click here to add this to my saved trials
33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
884
mi
from
Greenville, SC
Click here to add this to my saved trials
10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
1179
mi
from
Los Angeles, CA
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
1302
mi
from
Manhasset, NY
Click here to add this to my saved trials
4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
1322
mi
from
Miami Beach, FL
Click here to add this to my saved trials
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
618
mi
from
Nashville, TN
Click here to add this to my saved trials
1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
1142
mi
from
Orlando, FL
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
1492
mi
from
Portland, ME
Click here to add this to my saved trials
620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
1181
mi
from
Portsmouth, VA
Click here to add this to my saved trials
800 West 5th Avenue
Spokane, Washington 99210
1202
mi
from
Spokane, WA
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
1112
mi
from
Tampa, FL
Click here to add this to my saved trials
1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
897
mi
from
Akron, OH
Click here to add this to my saved trials
Akron, Ohio 44304
899
mi
from
Akron, OH
Click here to add this to my saved trials
1307
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
518
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
1209
mi
from
Allentown, PA
Click here to add this to my saved trials
Amarillo, Texas 79106
286
mi
from
Amarillo, TX
Click here to add this to my saved trials
Anderson, Indiana 46016
671
mi
from
Anderson, IN
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
805
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
808
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Annapolis, Maryland 21401
1155
mi
from
Annapolis, MD
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
600
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30342
798
mi
from
Atlanta, GA
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21225
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
6701 North Charles Street
Baltimore, Maryland 21204
443-849-3051
Greater Baltimore Medical Center Cancer Center The Sandra & Malcolm Berman Cancer Institute's comprehensive, multidisciplinary...
1147
mi
from
Baltimore, MD
Click here to add this to my saved trials
2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
1145
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
637
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
1215
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Billings, Montana 59101
780
mi
from
Billings, MT
Click here to add this to my saved trials
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
601 West 2nd Street
Bloomington, Indiana 47402
617
mi
from
Bloomington, IN
Click here to add this to my saved trials
1290
mi
from
Brooklyn, NY
Click here to add this to my saved trials
506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
1287
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Burlington, Vermont 05405
1356
mi
from
Burlington, VT
Click here to add this to my saved trials
1214
mi
from
Calgary,
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
1043
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
1051
mi
from
Charlottesville, VA
Click here to add this to my saved trials
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
611
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45267
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
725
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
899
mi
from
Cleveland, OH
Click here to add this to my saved trials
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
899
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clifton Springs, New York 14432
1143
mi
from
Clifton Springs, NY
Click here to add this to my saved trials
Colorado Springs, Colorado 80909
384
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Missouri 65203
308
mi
from
Columbia, MO
Click here to add this to my saved trials
811
mi
from
Columbus, GA
Click here to add this to my saved trials
1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
810
mi
from
Columbus, OH
Click here to add this to my saved trials
810
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, California 94524
1318
mi
from
Concord, CA
Click here to add this to my saved trials
Concord, North Carolina 28025
969
mi
from
Concord, NC
Click here to add this to my saved trials
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
1151
mi
from
Danville, PA
Click here to add this to my saved trials
Darby, Pennsylvania 19023
1219
mi
from
Darby, PA
Click here to add this to my saved trials
Dayton, Ohio 45420
746
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Illinois 62526
499
mi
from
Decatur, IL
Click here to add this to my saved trials
Denver, Colorado 80010
403
mi
from
Denver, CO
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
841
mi
from
Detroit, MI
Click here to add this to my saved trials
Drexel Hill, Pennsylvania
1218
mi
from
Drexel Hill, PA
Click here to add this to my saved trials
500
mi
from
Dubuque, IA
Click here to add this to my saved trials
East Orange, New Jersey 07018
1276
mi
from
East Orange, NJ
Click here to add this to my saved trials
East Stroudsburg, Pennsylvania 18301
1226
mi
from
East Stroudsburg, PA
Click here to add this to my saved trials
Edison, New Jersey 08818
1266
mi
from
Edison, NJ
Click here to add this to my saved trials
Elizabeth, New Jersey 07201
1276
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
Flint, Michigan 48532
821
mi
from
Flint, MI
Click here to add this to my saved trials
Fresno, California 93720
1205
mi
from
Fresno, CA
Click here to add this to my saved trials
Fresno, California 93720
1205
mi
from
Fresno, CA
Click here to add this to my saved trials
1600 Southwest Archer Road
Gainesville, Florida 32610
1049
mi
from
Gainesville, FL
Click here to add this to my saved trials
2635 North 7th Street
Grand Junction, Colorado 81502
588
mi
from
Grand Junction, CO
Click here to add this to my saved trials
689
mi
from
Green Bay, WI
Click here to add this to my saved trials
Green Bay, Wisconsin 54301
691
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greenbrae, California 94904
1343
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Greenville, North Carolina 27858
1138
mi
from
Greenville, NC
Click here to add this to my saved trials
Harrisonburg, Virginia 22801
1029
mi
from
Harrisonburg, VA
Click here to add this to my saved trials
1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
601
mi
from
Harvey, IL
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
1147
mi
from
Hershey, PA
Click here to add this to my saved trials
Honolulu, Hawaii 96813
3717
mi
from
Honolulu, HI
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
572
mi
from
Houston, TX
Click here to add this to my saved trials
661
mi
from
Huntsville, AL
Click here to add this to my saved trials
Huntsville, Alabama 35801
660
mi
from
Huntsville, AL
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
1482
mi
from
Hyannis, MA
Click here to add this to my saved trials
642
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46206
642
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46219
649
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Tennessee 38305
518
mi
from
Jackson, TN
Click here to add this to my saved trials
Jacksonville, Florida 32207
1058
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1441
mi
from
Jamaica Plain, MA
Click here to add this to my saved trials
Kalamazoo, Michigan 49007
718
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Kansas City, Missouri 64131
195
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Crosse, Wisconsin 54601
541
mi
from
La Crosse, WI
Click here to add this to my saved trials
Lackland Air Force Base, Texas 78236
578
mi
from
Lackland Air Force Base, TX
Click here to add this to my saved trials
961
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
1393
mi
from
Lebanon, NH
Click here to add this to my saved trials
1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
724
mi
from
Lexington, KY
Click here to add this to my saved trials