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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
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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

- 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


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

Type of Study:

Interventional

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:

No

Principal Investigator

Cynthia G. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Breastlink

Authority:

United States: Federal Government

Study ID:

CDR0000596257

NCT ID:

NCT00686166

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - DaytonKettering, Ohio  45429
LDS HospitalSalt Lake City, Utah  84143
CCOP - Grand RapidsGrand Rapids, Michigan  49503
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Sutter Cancer CenterSacramento, California  95816
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Wesley Medical CenterWichita, Kansas  67214
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Sutter Cancer Center at Roseville Medical CenterRoseville, California  95661
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
Poudre Valley HospitalFort Collins, Colorado  80524
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Mecosta County Medical CenterBig Rapids, Michigan  49307
Iredell Memorial HospitalStatesville, North Carolina  28677
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Polyclinic First HillSeattle, Washington  98122
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Wayne HospitalGreenville, Ohio  45331
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Ben Taub General HospitalHouston, Texas  77030
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Desert Regional Medical Center Comprehensive Cancer CenterPalm Springs, California  92262
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Mercy General Health PartnersMuskegon, Michigan  49443
AnMed Cancer CenterAnderson, South Carolina  29621
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
Memorial Hospital Cancer Center - Colorado SpringsColorado Springs, Colorado  80909
St. Luke's Texas Cancer Institute at St. Luke's Episcopal HospitalHouston, Texas  77030
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Hays Medical CenterHays, Kansas  67601
Hutchinson Hospital CorporationHutchinson, Kansas  67502
Island Hospital Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center Cancer CenterBurien, Washington  98166
Southwest Regional Cancer Center - CentralAustin, Texas  78705
Texas Oncology, PA at Texas Oncology Cancer Center - CentralAustin, Texas  78731
Texas Oncology, PA at South Austin Cancer CenterAustin, Texas  78745
Texas Oncology, PA at Texas Cancer Center Round RockRound Rock, Texas  78681
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Kansas City Cancer Centers - WestKansas City, Kansas  66112
Kansas City Cancer Center - Shawnee MissionShawnee Mission, Kansas  66204
Kansas City Cancer Centers - EastLee's Summit, Missouri  64064
Arizona Cancer Center at UMC Orange GroveTucson, Arizona  85704
Spectrum Health Reed City HospitalReed City, Michigan  49677
Texas Oncology, PA - Austin NorthAustin, Texas  78759
Texas Oncology, PA - Cedar ParkCedar Park, Texas  78613
Texas Oncology, PA - Seton WilliamsonRound Rock, Texas  78665
Texas Oncology, PA - San MarcosSan Marcos, Texas  78666
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029
Sutter Pacific Medical FoundationSanta Rosa, California  95403