Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
|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|
|Primary Completion Date :||August 2016|
|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.
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|