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Tracking Information | |||||||||||||||||
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First Received Date † | February 8, 2007 | ||||||||||||||||
Last Updated Date | May 7, 2009 | ||||||||||||||||
Start Date † | May 2007 | ||||||||||||||||
Current Primary Outcome Measures † |
Confirmed tumor response (complete or partial response) after 12 courses of study therapy [ Designated as safety issue: No ] | ||||||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||||||
Change History | Complete list of historical versions of study NCT00433550 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||||||||||
Brief Title † | Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer | ||||||||||||||||
Official Title † | A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma | ||||||||||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as irinotecan, 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. PURPOSE: This phase II trial is studying how well giving irinotecan together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic or unresectable locally advanced small bowel cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype.
In all groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Blood and serum samples are collected at baseline for UGT1A1 genotyping, celiac disease testing, and research studies, including translational and pharmacologic studies. After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study. |
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Study Phase | Phase II | ||||||||||||||||
Study Type † | Interventional | ||||||||||||||||
Study Design † | Treatment | ||||||||||||||||
Condition † | Small Intestine Cancer | ||||||||||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status † | Recruiting | ||||||||||||||||
Enrollment † | 33 | ||||||||||||||||
Completion Date | |||||||||||||||||
Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts †† | |||||||||||||||||
Location Countries † | United States | ||||||||||||||||
Expanded Access Status | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT ID † | NCT00433550 | ||||||||||||||||
Responsible Party | Jan C. Buckner, North Central Cancer Treatment Group | ||||||||||||||||
Secondary IDs †† | NCCTG-N0543 | ||||||||||||||||
Study Sponsor † | North Central Cancer Treatment Group | ||||||||||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||
Verification Date | May 2009 | ||||||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |