Status:
COMPLETED
Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Pfizer
Conditions:
Small Intestine Adenocarcinoma
Recurrent Small Intestine Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well giving irinotecan hydrochloride together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic or unresectable locally...
Detailed Description
PRIMARY OBJECTIVE: To assess the confirmed tumor response of the combination of oxaliplatin, irinotecan (irinotecan hydrochloride), and capecitabine in patients with advanced adenocarcinoma of the sm...
Eligibility Criteria
Inclusion
- 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 \< 2 cm, spiral computed tomography (CT) scan imaging must be used for tumor assessments
- Life expectancy \>= 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) =\< 5 x upper normal limit (UNL); =\< 2.5 x UNL if no liver metastases
- Total bilirubin:
- For 6/6 patients: =\< upper limit of normal (ULN)
- For 6/7 or 7/7 patients: =\< 2.0 x ULN
- Hemoglobin \>= 9.0 g/dL
- Creatinine =\< 1.5 x UNL (if \> 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 =\< 7 days prior to registration, for women of childbearing potential only
- Exclusion Criteria
- Prior chemotherapy regimen for advanced small bowel cancer (prior adjuvant chemotherapy with fluorouracil (5FU)/leucovorin is permitted if last dose was administered \>= 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
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00433550
Start Date
May 1 2007
End Date
May 1 2016
Last Update
August 24 2017
Active Locations (115)
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1
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
2
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
3
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
4
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403