Neoadjuvant Cetuximab, Fluorouracil, and Pelvic Irradiation in Treating Patients With Locally Advanced or Locally Recurrent Rectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed rectal adenocarcinoma meeting 1 of the following staging criteria:
• * Locally advanced disease
• * Resectable (uT3) disease
• * Primary gross transmural tumor that is not adherent to adjacent pelvic structures by endorectal ultrasound
• * Primary tethered or unresectable (cT4 or uT4) disease
• * Primary tumor is contiguous with or adherent or fixed to adjacent pelvic structures by clinical exam and CT scan
• * Primary surgery would likely leave residual tumor
• * Small volume extrapelvic metastases allowed
• * Recurrent disease after definitive resection
• * Disease limited to the pelvis
• Requires combined modality treatment
• Epidermal growth factor receptor status-positive, -negative, or -unknown
• If previously treated with adjuvant fluorouracil-based chemotherapy, no disease recurrence during or within 12 months after completion of adjuvant therapy
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0 -1
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Hemoglobin \> 8.0 g/dL
• Platelet count \> 150,000/mm\^3
• Hepatic
• Not specified
• Renal
• Creatinine ≤ 1.5 times upper limit of normal
• Cardiovascular
• No myocardial infarction within the past 6 months
• No evidence of uncontrolled congestive heart failure requiring therapy
• Other
• 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 known severe hypersensitivity to cetuximab or any of its excipients
• No uncontrolled infection
• No high-grade bowel obstruction (bowel lumen ≤ 1 cm) unless patient has undergone protective surgical diversion or endoscopic stenting procedure
• No other concurrent medical or psychiatric condition or disease that would preclude study participation
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study treatment
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior cetuximab
• No prior murine or chimeric monoclonal antibody therapy
• No prior biological response modifiers for metastatic colorectal cancer
• No concurrent anti-vascular endothelial growth factor/Flk-1 monoclonal antibody therapy
• No other concurrent antibody therapy or immunotherapy
• No concurrent gene therapy
• No concurrent vaccine therapy
• No concurrent angiogenesis inhibitors, including thalidomide
• Chemotherapy
• See Disease Characteristics
• No prior chemotherapy for metastatic colorectal cancer
• No other concurrent chemotherapy
• Endocrine therapy
• No concurrent hormonal therapy
• Radiotherapy
• No prior radiotherapy for metastatic colorectal cancer
• No prior pelvic radiotherapy
• No other concurrent radiotherapy
• Surgery
• See Disease Characteristics
• Fully recovered from prior oncologic or other major surgery
• Other
• No other prior therapy that targets the epidermal growth factor receptor pathway
• No other concurrent experimental therapy or drugs
• No concurrent matrix metalloprotease inhibitors
• No concurrent participation in another clinical study