S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: cetuximab; capecitabine; oxaliplatin; therapeutic surgical procedure; radiation therapy
Intervention description: Chemotherapy cycle 1: Cetuximab, 400 mg/m^2, IV, Day 1; Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78; Chemotherapy Cycle 1: Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84); Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
Chemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78; Surgical resection; IMRT (intensity-modulated radiation therapy)
Intervention MeSH terms: Capecitabine; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      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.
    

Eligibility 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