Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
Condition: Colorectal Cancer
MeSH terms: Adenocarcinoma
Intervention: selenomethionine; capecitabine; oxaliplatin; laboratory biomarker analysis; pharmacological study; adjuvant therapy; neoadjuvant therapy; therapeutic conventional surgery; radiation therapy
Intervention MeSH terms: Selenium; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the rectum; stage II rectal cancer; stage III rectal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together With
      selenomethionine and radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well selenomethionine works when given together
      with capecitabine, oxaliplatin, and radiation therapy in treating patients undergoing surgery
      for newly diagnosed stage II or stage III rectal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed rectal adenocarcinoma that is involving the distal 12 cm of
             the rectum (above the anal verge)

               -  Staged within 8 weeks prior to initiation of study by endoscopic ultrasound OR
                  MRI or CT scan if endorectal ultrasound is non-conclusive or non-tolerable

               -  T3-T4 tumor or evidence of lymph node involvement defined by the presence of at
                  least 1 enlarged peri-rectal lymph node

          -  No evidence of distant or known metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

          -  Life expectancy > 1 year

          -  Leukocytes ≥ 3,000/µL

          -  Absolute neutrophil count ≥ 1,500/µL

          -  Platelet count ≥ 100,000/µL

          -  Total bilirubin ≤ upper limit of normal (ULN)

          -  AST/ALT ≤ 2.5 times ULN

          -  Creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min

          -  Able to receive oral medication

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other concurrent or previous malignancies unless disease free for > 5 years
             (excluding nonmelanoma skin cancer)

          -  No neuropathy ≥ grade 2

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biologic composition to oxaliplatin, capecitabine, or selenomethionine

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness/social situations that would limit compliance with study
                  requirements

        PRIOR CONCURRENT THERAPY:

          -  No prior radiotherapy to the pelvis

          -  No prior chemotherapy

          -  No other concurrent investigational or anticancer agents or therapies

          -  No concurrent vitamin B6 supplementation (except as part of a standard, multivitamin
             supplement)