Combination Chemotherapy and Bevacizumab With or Without Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum Read More

DISEASE CHARACTERISTICS:

• Histologically or pathologically confirmed adenocarcinoma of the rectum

  • Clinical stage T1, N1; T2, N1; T3, N0; or T3, N1 by endorectal ultrasonography (ERUS)

    • No bulky N2 disease by either ERUS or MRI

    • No primary fixed or unresectable (clinical stage T4) rectal cancer or recurrent colorectal cancer limited to the pelvis

      • Primary unresectable rectal cancer is defined as a primary rectal tumor which on the basis of either physical exam, ERUS or pelvic MRI is deemed to be adherent or fixed to adjacent pelvic structures

• Must be a candidate for all of the following:

  • Neoadjuvant chemoradiotherapy
  • Systemic therapy with fluorouracil, leucovorin calcium, oxaliplatin (FOLFOX), and bevacizumab
  • Complete surgical resection via low anterior resection prior to administration of any therapy
• No low-lying tumors deemed to require an abdominal perineal resection
• No large or bulky tumors that require a diverting colostomy or placement of an endorectal stent prior to treatment initiation
• No clinical evidence of metastatic disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count > 150,000/mm^3
• Hemoglobin > 8.0 g/dL
• Creatinine ≤ 1.5 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No arterial thrombotic event within the past 6 months, including stable or unstable angina, myocardial infarction (MI), or cerebral vascular accident (CVA)

  • Deep venous thrombosis, pulmonary embolus, MI, CVA, atrial fibrillation, or any other conditions occurring more than 6 months ago allowed provided patient is on stable doses of anticoagulant therapy
• No other medical or psychiatric condition or disease that would preclude study therapy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy or surgery for rectal cancer
• No prior pelvic radiotherapy

• No other concurrent experimental therapy, including any of the following:

  • Chemotherapy
  • Radiotherapy
  • Hormonal therapy
  • Antibody therapy
  • Immunotherapy
  • Gene therapy
  • Vaccine therapy
  • Angiogenesis inhibitors
  • Matrix metalloprotease inhibitors
  • Thalidomide
  • Anti-vascular endothelial growth factor/Flk-1 monoclonal antibody
  • Any other experimental drugs