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

Inclusion Criteria

• •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