Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
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|ClinicalTrials.gov Identifier: NCT01730586|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : August 16, 2016
The goal of this clinical research study is to learn if abraxane can help to control colorectal and/or small bowel cancer. The safety of this drug will also be studied.
Abraxane is designed to block cancer cells from dividing, which may cause them to die.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Cancer of Gastrointestinal Tract||Drug: Abraxane||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Abraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
- Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma [ Time Frame: 21 days ]Sample size of 15 patients with CIMP-high required to demonstrate a response rate of 20% using a binomial one-sample test with a two-sided alpha of 0.025 and power of 91%. For second disease group, 10 small intestinal adenocarcinomas patients enrolled to test if a null hypothesis of ≤1% response rate is different from an alternative hypothesis of a response rate of 20% using a binomial one-sample test with a two-sided alpha of 0.025 and power of 0.85. A Bonferroni's correction used to account for the multiple testing (overall alpha=0.05/2 tests). Pearson chi-square (or Fisher's exact test) or t-test (or Wilcoxon rank test) used to determine differences between responder and non-responders.
- Progression-Free Survival [ Time Frame: 21 days ]Overall survival and time to progression functions will be estimated using the Kaplan-Meier method. Patients who drop out of the study will be included in the time to event data analysis as "censored data". For progression-free survival as a binary endpoint, the intent-to-treat analysis will be performed using all available patients. A two-sided log-rank test will be used to assess the differences of time to events between groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730586
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Overman, MD||M.D. Anderson Cancer Center|