S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/20/2018
Start Date:February 2009
End Date:March 2018

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A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in
different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses
high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before
surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
removed.

PURPOSE: This phase II trial is studying the side effects and how well giving oxaliplatin,
capecitabine, and cetuximab together with radiation therapy followed by surgery works in
treating patients with stage II or stage III rectal cancer.

OBJECTIVES:

- To assess the pathologic complete response rate for the combination of oxaliplatin,
capecitabine, and cetuximab alone and concurrently with external beam radiotherapy for
patients with adenocarcinoma of the rectum, stages II and III with wild-type K-ras.

- To estimate the 3-year disease-free survival probability in this patient population when
treated with this regimen.

- To assess the frequency and severity of toxicities associated with this regimen in these
patients.

- To explore, preliminarily, the association between expression levels of genes involved
in the DNA repair, EGFR (epidermal growth factor receptor), angiogenesis, and 5-FU
pathway (i.e., k-ras, TS [Thymidylate Synthase], ERCC-1 [excision repair cross
complementing-1), TP [Thymidine phosphorylase], DPD [Dihydropyrimidine dehydrogenase],
EGFR, VEGF [vascular endothelial growth factor], and IL-8 [interleukin-8]) and
pathologic complete response. (Due to advances in methodology, the translational
medicine objectives are being reconsidered. Therefore, results for this objective are
not reported)

- To explore, preliminarily, the intratumoral gene expression levels of these genes after
completion of study treatment.(Due to advances in methodology, the translational
medicine objectives are being reconsidered. Therefore, results for this objective are
not reported)

- To obtain, preliminarily, data on genomic polymorphisms of these genes for correlation
with clinical outcome and toxicity. (Due to advances in methodology, the translational
medicine objectives are being reconsidered. Therefore, results for this objective are
not reported)

OUTLINE: This is a multicenter study.

- Neoadjuvant therapy (course 1): Patients receive oxaliplatin IV over 2 hours once a week
for 5 weeks, oral capecitabine twice daily 5 days a week for 5 weeks, and cetuximab IV
over 1-2 hours once a week for 5 weeks.

- Neoadjuvant therapy with concurrent radiotherapy (course 2): Beginning two weeks later,
patients receive oxaliplatin IV over 2 hours once a week in weeks 1, 2, 4, and 5.
Patients also receive capecitabine and cetuximab as in course 1. Patients also undergo
external beam radiotherapy 5 days a week for 5 weeks beginning in week 1.

Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
undergo surgery 3-8 weeks after completion of chemoradiotherapy.

Blood samples are collected for germline polymorphism testing and tissue samples are
collected and assessed for gene expression analysis.

After completion of study treatment, patients are followed every 6 months for 4 years.

DISEASE CHARACTERISTICS:

- Biopsy-proven primary adenocarcinoma of the rectum

- Stage II or III disease

- The distal border of the tumor must be at or below the peritoneal reflection,
defined as within 12 cm of the anal verge by proctoscopic examination

- No recurrent disease

- Must have wild-type k-ras status

- Measurable and/or nonmeasurable disease

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Leukocyte count ≥ 3,000/mcL

- Granulocyte count ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate
transaminase)≤ 2.5 times ULN

- Creatinine clearance > 50 mL/min

- No prior severe reaction to a monoclonal antibody

- Willing to have specimens submitted

- No peripheral neuropathy ≥ grade 2

- No known existing uncontrolled coagulopathy

- No evidence of current high-grade obstruction

- At least 2 weeks since prior diverting procedure

- No history of allergy to platinum compounds or to antiemetics appropriate for
administration in conjunction with protocol treatment

- No prior unanticipated severe reaction to fluoropyrimidine therapy or known
sensitivity to fluorouracil or known DPD deficiency

- No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow
that would impair the ingestion or absorption of capecitabine

- No uncontrolled intercurrent illness

- No ongoing or active infection

- No symptomatic congestive heart failure or unstable angina pectoris

- No cardiac arrhythmia or myocardial infarction within the past 12 months

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior malignancy allowed except for adequately treated basal cell or squamous cell
skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient
has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

- Recovered from any recent major surgeries (e.g., coronary artery bypass graft,
transurethral resection of prostate, or abdominal surgery)

- No prior chemotherapy, radiotherapy, or targeted therapy for this tumor

- More than 4 weeks since prior investigational agents

- No concurrent anti-retroviral therapy for HIV
We found this trial at
130
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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2401 West Belvedere Avenue
Baltimore, Maryland 21215
(410) 601-4688
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital The Alvin & Lois Lapidus Cancer...
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2720 Clare Avenue
Bremerton, Washington 98310
360-479-6154
Olympic Hematology and Oncology We provide outpatient cancer services in a refined environment designed specifically...
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Bremerton, WA
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200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1 Saint francis dr
Greenville, South Carolina 29601
(864) 255-1000
Bon Secours St. Francis Health System This 245-bed, all-private-room facility is located near downtown Greenville,...
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2500 N. State St.
Jackson, Mississippi 39216
(601) 815-6802
University of Mississippi Cancer Clinic he Cancer Institute is home to the ACT Tobacco Treatment,...
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1415 E. Kincaid
Mount Vernon, Washington 98273
360-424-4111
Skagit Valley Hospital Cancer Care Center We know that treatment takes its toll physically, emotionally...
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19500 10th Ave NE # 100
Poulsbo, Washington 98370
(360) 598-7500
Harrison Poulsbo Hematology and Onocology Harrison Poulsbo's new Hematology & Oncology center provides outpatient cancer...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
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201 16th Avenue East
Seattle, Washington 98112
(206) 326-3000
Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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747 Broadway
Seattle, Washington 98122
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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1501 North Campbell Avenue
Tucson, Arizona 85719
(520) 694-CURE (2873)
Arizona Cancer Center at University of Arizona Health Sciences Center Since being established in 1976,...
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820 North Chelan Avenue
Wenatchee, Washington 98801
509) 663-8711
Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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American Fork, Utah 84003
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1211 24th Street
Anacortes, Washington 98221
(360) 299-1300
Island Hospital Cancer Care Center at Island Hospital sland Hospital is the center for health...
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Anderson, South Carolina 29621
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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...
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Austin, Texas 78759
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300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
(317) 528-5000
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
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3301 Squalicum Parkway
Bellingham, Washington 98225
(360) 788-8222
St. Joseph Cancer Center The PeaceHealth St. Joseph Cancer Center offers a full-range of services...
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2450 Ashby Ave.
Berkeley, California 94705
(510) 204-4444
Alta Bates Summit Comprehensive Cancer Center Our Comprehensive Cancer Services are comprised of exceptional, state-of-the-art...
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605 Oak St
Big Rapids, Michigan 49307
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16233 Sylvester Rd SW #110
Burien, Washington 98166
(206) 439-5577
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Burlingame, California 94010
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1303 North Main Street
Cedar City, Utah 84721
(435) 868-5680
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Cedar Park, Texas 78613
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Charleston, South Carolina 29401
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Colorado Springs, Colorado 80909
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1 Wyoming St
Dayton, Ohio 45409
(937) 208-2300
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Dayton, Ohio 45406
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Dayton, Ohio 45420
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9000 North Main Street
Dayton, Ohio 45415
(937) 734-5800
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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2300 N. Edward Street
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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2799 W Grand Blvd
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Fort Scott, Kansas 66701
(620) 223-8589
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105 Mcknight Drive
Franklin, Ohio 45005
513-424-2111
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Goldsboro, North Carolina 27534
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250 Cherry St SE
Grand Rapids, Michigan 49503
(616) 685-5225
Lacks Cancer Center at Saint Mary's Health Care Mercy Health Lacks Cancer Center was one...
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100 Michigan Street, NE, MC012
Grand Rapids, Michigan 49503
(616) 391-1230
CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
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Grand Rapids, Michigan 49503
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835 Sweitzer St
Greenville, Ohio 45331
(937) 548-1141
Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
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2220 Canterbury Drive
Hays, Kansas 67601
785.623.5000
Hays Medical Center Hays Medical Center is a private, not-for-profit hospital formed by the 1991...
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One Baylor Plaza
Houston, Texas 77030
(713) 798-4951
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1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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Hutchinson, Kansas 65702
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
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Issaquah, Washington 98029
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Kansas City, Kansas 66112
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
913.588.1227#sthash.z9pLd
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center The Kansas Masons...
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Kansas City, Missouri 64108
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Kansas City, Missouri 64131
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8700 N. Green Hills Road
Kansas City, Missouri 64154
816.746.4570
Kansas City Cancer Centers - North Through world-class research and patient care, The University of...
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Kennewick, Washington 99336
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
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Knoxville, Tennessee 37920
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325 Maine Street
Lawrence, Kansas 66044
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Lee's Summit, Missouri 64064
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315 W. 15th St.
Liberal, Kansas 67905
(620) 629-6727
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500 E 1400 N
Logan, Utah 84341
(435) 716-1000
Logan Regional Hospital Logan Regional Hospital is a nonprofit, full-service regional medical center and level...
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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5121 South Cottonwood Street
Murray, Utah 84157
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1700 Oak Ave.
Muskegon, Michigan 49444
231-672-2000
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720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
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12200W. 110th Street
Overland Park, Kansas 66210
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Kansas City Cancer Centers - Southwest Through world-class research and patient care, The University of...
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1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
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2809 Denny Ave
Pascagoula, Mississippi 39581
228-809-5251
Regional Cancer Center at Singing River Hospital The Regional Cancer Center team at Singing River...
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Pittsburg, Kansas 66762
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124 Commodore, Ste. A
Pratt, Kansas 67124
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300 N Patterson Rd
Reed City, Michigan 49677
(231) 832-3271
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1100 Reid Pkwy
Richmond, Indiana 47374
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Rochester, New York 14623
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Round Rock, Texas 78665
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Sacramento, California 95816
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1380 East Medical Center Drive
Saint George, Utah UT84790
(435) 251-1000
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