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

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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


- 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.

- To explore, preliminarily, the intratumoral gene expression levels of these genes after
completion of study treatment.

- To obtain, preliminarily, data on genomic polymorphisms of these genes for correlation
with clinical outcome and toxicity.

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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate

Outcome Time Frame:

15-20 weeks from registration

Safety Issue:


Principal Investigator

Cynthia G. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

July 2017

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the rectum
  • stage IIA rectal cancer
  • stage IIB rectal cancer
  • stage IIC rectal cancer
  • stage IIIA rectal cancer
  • stage IIIB rectal cancer
  • stage IIIC rectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
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Sutter Cancer Center Sacramento, California  95816
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Wesley Medical Center Wichita, Kansas  67214
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Front Range Cancer Specialists Fort Collins, Colorado  80528
Peninsula Medical Center Burlingame, California  94010
Sutter Health - Western Division Cancer Research Group Greenbrae, California  94904
Sutter Cancer Center at Roseville Medical Center Roseville, California  95661
California Pacific Medical Center - California Campus San Francisco, California  94118
Sutter Solano Medical Center Vallejo, California  94589
Poudre Valley Hospital Fort Collins, Colorado  80524
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Mecosta County Medical Center Big Rapids, Michigan  49307
Iredell Memorial Hospital Statesville, North Carolina  28677
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Polyclinic First Hill Seattle, Washington  98122
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
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Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
Wayne Hospital Greenville, Ohio  45331
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Ben Taub General Hospital Houston, Texas  77030
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Desert Regional Medical Center Comprehensive Cancer Center Palm Springs, California  92262
Providence Cancer Center at Providence Hospital Mobile, Alabama  36608
Mercy General Health Partners Muskegon, Michigan  49443
AnMed Cancer Center Anderson, South Carolina  29621
U.T. Medical Center Cancer Institute Knoxville, Tennessee  37920-6999
Memorial Hospital Cancer Center - Colorado Springs Colorado Springs, Colorado  80909
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston, Texas  77030
Mount Carmel Regional Cancer Center Pittsburg, Kansas  66762
Kansas City Cancer Centers - Southwest Overland Park, Kansas  66210
Hays Medical Center Hays, Kansas  67601
Hutchinson Hospital Corporation Hutchinson, Kansas  67502
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
Southwest Regional Cancer Center - Central Austin, Texas  78705
Texas Oncology, PA at Texas Oncology Cancer Center - Central Austin, Texas  78731
Texas Oncology, PA at South Austin Cancer Center Austin, Texas  78745
Texas Oncology, PA at Texas Cancer Center Round Rock Round Rock, Texas  78681
Kansas City Cancer Centers - North Kansas City, Missouri  64154
Kansas City Cancer Centers - South Kansas City, Missouri  64131
Arizona Cancer Center at University Medical Center North Tucson, Arizona  85719
Kansas City Cancer Centers - West Kansas City, Kansas  66112
Kansas City Cancer Center - Shawnee Mission Shawnee Mission, Kansas  66204
Kansas City Cancer Centers - East Lee's Summit, Missouri  64064
Arizona Cancer Center at UMC Orange Grove Tucson, Arizona  85704
Spectrum Health Reed City Hospital Reed City, Michigan  49677
Texas Oncology, PA - Austin North Austin, Texas  78759
Texas Oncology, PA - Cedar Park Cedar Park, Texas  78613
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Texas Oncology, PA - San Marcos San Marcos, Texas  78666
Swedish Medical Center - Issaquah Campus Issaquah, Washington  98029
Sutter Pacific Medical Foundation Santa Rosa, California  95403