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A Phase I/II Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer

1. To determine the MTD and DLTs of oxaliplatin and capecitabine when combined with C225 and radiotherapy (Phase I) 2. To determine the pathologic response rate of C225 in combination with this neoadjuvant cytotoxic regimen (Phase II)

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Capecitabine
  • drug : Oxaliplatin
  • drug : Cetuximab

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Patients with histologically confirmed adenocarcinoma of the rectum: EUS stage T3 or T4 or N1 disease are eligible (includes T3 N0, T3 N1, T4 N0, T4 N1, T1-4 N1). Rectal cancers will be defined as those whose distal border extends to within 12cm of the anal verge. - Age >= 18. - Karnofsky performance status >= 70. - Creatinine within normal institutional limits or creatinine clearance > 60mL/min/1.73m2 for patients with serum creatinine levels above institutional normal. - Negative urine pregnancy test if a woman of child bearing potential (WOCBP). - WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication. - WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the treatment. - Ability to swallow pills without difficulty. - No prior pelvic or whole abdominal radiotherapy. - Patients must have adequate organ and marrow function as defined below: Leukocyte count > 3,500. Platelet count > 100,000. SGOT, SGPT, Alk. Phos: < 2.5x institutional upper limits of normal. Total bilirubin < 1.5x institutional normal institutional limits.

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Heidi Kaiser
6507240079
Not Recruiting

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