Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas
|ClinicalTrials.gov Identifier: NCT01730586|
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
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|
|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 (SBA) [ Time Frame: Assessed at 21 day cycle; Restaging done every 3 cycles ]Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): >20% increase (absolute increase >5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not <4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.
- Progression-Free Survival (PFS) [ Time Frame: Assessed at first cycle (21 days), up to 12 months ]The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as "censored data".
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|