Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer

Inclusion Criteria

• Confirmation UDP glucuronosyltransferase 1 family, polypeptide A complex locus (UGT1A1) TA indel genotype of 6/6, 6/7, or 7/7 after pre-registration but prior to registration
• Patient willingness to provide a serum sample for analysis for celiac disease (tissue transglutaminase antibodies)
• Small bowel adenocarcinoma, either metastatic or locally advanced and not surgically resectable; NOTE: periampullary carcinoma and appendiceal cancer are not eligible
• Histologic or cytologic confirmation of adenocarcinoma consistent with small bowel origin; biopsy can be of primary tumor or can be from a metastatic site if there is a primary small bowel tumor currently or previously present
• Measurable disease; for patients with lesions >= 1 cm but = 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• >= 4 weeks since prior major surgery to time of registration
• >= 2 weeks from completion of any radiation treatment
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelets >= 100,000/mm^3
• Serum glutamic oxaloacetic transaminase (SGOT) = = 9.0 g/dL
• Creatinine = 1.5 x UNL, calculated creatinine clearance should be checked.; if it is > 60 mL/min, then the patient is eligible for the study)
• Negative pregnancy test done = = 3 months prior to registration); prior oxaliplatin or irinotecan use as adjuvant therapy is not permitted
• Prior radiotherapy to > 25% of bone marrow
• Active or uncontrolled infection
• Evidence of serious intercurrent illness (e.g., unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
• Pregnant women; women of child-bearing potential and men must agree to use adequate contraception (diaphragm, birth control pills, injections, foams, intrauterine device [IUD], or abstinence, etc.) for the duration of study participation; if a woman becomes pregnant or suspects that she is pregnant while participating in this study, she should inform her treating physician immediately and all study treatment discontinued
• Nursing women; breast-feeding should be discontinued when the mother is treated with these agents
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Current evidence of other malignancy besides small bowel adenocarcinoma, with exception of non-melanoma skin cancer
• Known central nervous system metastases or carcinomatous meningitis
• Preexisting sensory neuropathy >= grade 2 from any cause interfering with function
• Concurrent therapy with sorivudine, brivudine, lamivudine, or stavudine