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

Completed · Phase 2

Conditions studied: Small Intestine Adenocarcinoma, Recurrent Small Intestine Cancer

In brief

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 advanced small bowel cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Key facts

Study ID

NCT00433550

Run by

Alliance for Clinical Trials in Oncology

People needed

33

Starts

2007-05-01

Expected to finish

2016-05-01

Last updated by the study team

2017-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• Cedar Rapids Oncology Associates — Cedar Rapids, Iowa, United States
• Mercy Regional Cancer Center at Mercy Medical Center — Cedar Rapids, Iowa, United States
• CCOP - Iowa Oncology Research Association — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at John Stoddard Cancer Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at Mercy Cancer Center — Des Moines, Iowa, United States
• Mercy Cancer Center at Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Lutheran Hospital — Des Moines, Iowa, United States
• Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
• Mercy Medical Center - Sioux City — Sioux City, Iowa, United States
• St. Luke's Regional Medical Center — Sioux City, Iowa, United States
• Cancer Center of Kansas, PA - Chanute — Chanute, Kansas, United States
• Cancer Center of Kansas, PA - Dodge City — Dodge City, Kansas, United States
• Cancer Center of Kansas, PA - El Dorado — El Dorado, Kansas, United States
• Cancer Center of Kansas - Fort Scott — Fort Scott, Kansas, United States
• Cancer Center of Kansas-Independence — Independence, Kansas, United States
• Cancer Center of Kansas, PA - Kingman — Kingman, Kansas, United States
• Lawrence Memorial Hospital — Lawrence, Kansas, United States
• Cancer Center of Kansas, PA - Liberal — Liberal, Kansas, United States
• Cancer Center of Kansas, PA - Newton — Newton, Kansas, United States
• Cancer Center of Kansas, PA - Parsons — Parsons, Kansas, United States
• Cancer Center of Kansas, PA - Pratt — Pratt, Kansas, United States
• Cancer Center of Kansas, PA - Salina — Salina, Kansas, United States
• Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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