Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
NCT00433550
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer | |||
Official Title ICMJE | A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma | |||
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 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. | |||
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 small bowel when dosed according to UGT1A1 genotype. SECONDARY OBJECTIVES:
OUTLINE: Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype. GROUP 1 (6/6 UGT1A1 genotype): Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 2-15. GROUP 2 (6/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses. GROUP 3 (7/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses. In all groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Goetz MP, McKean HA, Reid JM, Mandrekar SJ, Tan AD, Kuffel MA, Safgren SL, McGovern RM, Goldberg RM, Grothey AA, McWilliams R, Erlichman C, Ames MM. UGT1A1 genotype-guided phase I study of irinotecan, oxaliplatin, and capecitabine. Invest New Drugs. 2013 Dec;31(6):1559-67. doi: 10.1007/s10637-013-0034-9. Epub 2013 Oct 10. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 33 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2016 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00433550 | |||
Other Study ID Numbers ICMJE | NCCTG-N0543 NCI-2009-00650 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) CDR0000528263 ( Registry Identifier: PDQ (Physician Data Query) ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Alliance for Clinical Trials in Oncology | |||
Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Alliance for Clinical Trials in Oncology | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |