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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



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Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
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