Trial Search Results

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

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. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: capecitabine
  • Drug: oxaliplatin
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy

Phase:

Phase 2

Eligibility


- Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2

   - Patient must have histologically confirmed invasive adenocarcinoma of the rectum;
   Note: patients with rectal tumors suspicious for invasion also are eligible

   - Distal border of the patient's tumor must be within 8 cm from the anal verge as
   measured on endoscopic exam

   - Patients with tumors fixed to adjacent structures on digital exam are NOT eligible

   - Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or
   endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4
   tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm

   - Patients with positive perirectal nodes on ERUS examination are NOT eligible

   - Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are
   NOT eligible

   - Patients with the following conditions are NOT allowed on study:

      - Metastatic disease or other primaries (patient must have had chest X-ray/computed
      tomography [CT] and abdominal & pelvic CT/MRI with IV contrast, as well as a
      colonoscopy)

      - Previously documented history of familial adenomatous polyposis

      - Previously documented history of hereditary non-polyposis colorectal cancer
      diagnosed clinically (Amsterdam II criteria) or by genetic testing

      - History of inflammatory bowel disease

      - History of prior radiation treatments to pelvis

      - Clinically significant peripheral sensory or motor neuropathy (defined as
      symptomatic weakness, paresthesia or sensory alteration described to be
      interfering with function, interfering with activities of daily living, disabling
      or life-threatening)

      - History of any clinically significant cardiac disease (i.e., class 3-4 congestive
      heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia,
      and/or myocardial infarction within the last 6 months)

      - History of uncontrolled seizures or clinically significant central nervous system
      disorders

      - History of psychiatric conditions or diminished mental capacity that could
      compromise the giving of informed consent, or interfere with study compliance

      - History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin

      - History of difficulty or inability to take or absorb oral medications

   - White blood cells (WBC) >= 3000/mm^3

   - Absolute neutrophil count (ANC) > 1,500/mm^3

   - Hemoglobin > 9.5 mg/dl

   - Platelet count >= 100,000/mm^3

   - Total bilirubin =< 3 mg/dl

   - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
   alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0
   times institutional upper limit of normal (ULN)

   - Alkaline phosphatase =< 2.0 times ULN

   - Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation

   - Patients who have experienced a prior malignancy must have received potentially
   curative therapy for that malignancy, and must be cancer-free for at least five years
   from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin
   carcinoma, or in-situ carcinomas)

   - Patients of reproductive potential must agree to use an effective method of birth
   control when undergoing treatments with known or possible mutagenic or teratogenic
   effects; all female participants of childbearing potential must have a negative urine
   or serum pregnancy test within two weeks prior to study registration

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Moe Jalali
6507244023
Not Recruiting