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Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01730586
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Cancer of Gastrointestinal Tract
Intervention Drug: Abraxane
Enrollment 34
Recruitment Details Recruitment Period: November 2012 to October 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Abraxane
Hide Arm/Group Description Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
Period Title: Overall Study
Started 34
Completed 21
Not Completed 13
Reason Not Completed
Progressive Disease             2
Inadequate Trial             8
Adverse Event             2
Hospice             1
Arm/Group Title Abraxane
Hide Arm/Group Description Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
59
(34 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
14
  41.2%
Male
20
  58.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
Colorectal Cancer Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Small Bowel Adenocarcinoma (SBA)
13
  38.2%
CIMP-high Colorectal Cancer (CRC)
21
  61.8%
[1]
Measure Description: Histologically or cytologically confirmed colorectal adenocarcinoma (CpG island methylator phenotype (CIMP-high)) or small bowel adenocarcinoma
1.Primary Outcome
Title Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
Hide Description 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.
Time Frame Assessed at 21 day cycle; Restaging done every 3 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
In the CIMP-CRC arm 15 participants were considered efficacy evaluable [Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)], and three were not evaluable in SBA arm.
Arm/Group Title CIMP-high Colorectal Cancer Small Bowel Adenocarcinoma (SBA)
Hide Arm/Group Description:
Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
Overall Number of Participants Analyzed 15 10
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
Partial Response
0
   0.0%
2
  20.0%
Stable Disease
3
  20.0%
3
  30.0%
Progressive Disease
12
  80.0%
5
  50.0%
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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".
Time Frame Assessed at first cycle (21 days), up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
For progression-free survival, the intent-to-treat analysis performed using all available participants.
Arm/Group Title CIMP-high Colorectal Cancer Small Bowel Adenocarcinoma
Hide Arm/Group Description:
Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
Overall Number of Participants Analyzed 21 13
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(1.7 to 2.5)
3.2
(2.6 to 3.8)
Time Frame Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abraxane
Hide Arm/Group Description Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.
All-Cause Mortality
Abraxane
Affected / at Risk (%)
Total   0/34 (0.00%)    
Hide Serious Adverse Events
Abraxane
Affected / at Risk (%) # Events
Total   20/34 (58.82%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  1  3/34 (8.82%) 
Gastrointestinal disorders   
Small intestinal obstruction  1  6/34 (17.65%) 
Jejunal obstruction  1  1/34 (2.94%) 
Rectal pain  1  1/34 (2.94%) 
Nausea  1  1/34 (2.94%) 
General disorders   
Fever  1  1/34 (2.94%) 
Infections and infestations   
Urinary tract infection  1  1/34 (2.94%) 
Infection, Other - perirectal abcess  1  1/34 (2.94%) 
Metabolism and nutrition disorders   
Dehydration  1  1/34 (2.94%) 
Psychiatric disorders   
Confusion  1  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/34 (2.94%) 
Vascular disorders   
Hypotension  1  2/34 (5.88%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abraxane
Affected / at Risk (%) # Events
Total   34/34 (100.00%)    
Blood and lymphatic system disorders   
Abdominal distension  1  1/34 (2.94%)  1
Anemia  1  12/34 (35.29%)  15
Febrile neutropenia  1  3/34 (8.82%)  3
Endocrine disorders   
Hypothyroidism  1  1/34 (2.94%)  1
Eye disorders   
Blurred vision  1  4/34 (11.76%)  4
Eye disorders  1  1/34 (2.94%)  1
Gastrointestinal disorders   
Abdominal pain  1  9/34 (26.47%)  18
Ascites  1  2/34 (5.88%)  2
Constipation  1  8/34 (23.53%)  12
Diarrhea  1  10/34 (29.41%)  19
Dry mouth  1  1/34 (2.94%)  1
Duodenal obstruction  1  1/34 (2.94%)  1
Dyspepsia  1  1/34 (2.94%)  1
Flatulence  1  2/34 (5.88%)  2
Gastroesophageal reflux disease  1  3/34 (8.82%)  3
Gastrointestinal disorders - (Other)  1  1/34 (2.94%)  3
Gastroparesis  1  1/34 (2.94%)  1
Ileus  1  2/34 (5.88%)  2
Mucositis oral  1  7/34 (20.59%)  8
Nausea  1  14/34 (41.18%)  24
Rectal pain  1  1/34 (2.94%)  4
Small intestinal obstruction  1  1/34 (2.94%)  2
Vomiting  1  8/34 (23.53%)  12
General disorders   
Edema face  1  2/34 (5.88%)  2
Edema limbs  1  2/34 (5.88%)  2
Fatigue  1  21/34 (61.76%)  39
Fever  1  5/34 (14.71%)  5
Flu like symptoms  1  2/34 (5.88%)  2
Gait disturbance  1  1/34 (2.94%)  1
Localized edema  1  1/34 (2.94%)  1
Malaise  1  3/34 (8.82%)  4
Infections and infestations   
Infections and infestations - (Other)  1  2/34 (5.88%)  4
Lung infection  1  3/34 (8.82%)  3
Sepsis  1  1/34 (2.94%)  1
Sinusitis  1  1/34 (2.94%)  1
Soft tissue infection  1  1/34 (2.94%)  1
Upper respiratory infection  1  1/34 (2.94%)  1
Urinary tract infection  1  2/34 (5.88%)  2
Investigations   
Alanine aminotransferase increased  1  4/34 (11.76%)  4
Alkaline phosphatase increased  1  7/34 (20.59%)  7
Aspartate aminotransferase increased  1  4/34 (11.76%)  4
Blood bilirubin increased  1  3/34 (8.82%)  5
Creatinine increased  1  1/34 (2.94%)  1
Investigations - (Other)  1  1/34 (2.94%)  1
Neutrophil count decreased  1  5/34 (14.71%)  6
Platelet count decreased  1  5/34 (14.71%)  8
Weight loss  1  5/34 (14.71%)  5
White blood cell decreased  1  1/34 (2.94%)  1
Metabolism and nutrition disorders   
Anorexia  1  9/34 (26.47%)  10
Dehydration  1  5/34 (14.71%)  6
Hyperuricemia  1  1/34 (2.94%)  1
Hypoalbuminemia  1  1/34 (2.94%)  2
Hypocalcemia  1  1/34 (2.94%)  1
Hypokalemia  1  3/34 (8.82%)  3
Hypomagnesemia  1  7/34 (20.59%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia  1  12/34 (35.29%)  20
Back pain  1  3/34 (8.82%)  3
Bone pain  1  4/34 (11.76%)  6
Generalized muscle weakness  1  1/34 (2.94%)  1
Joint range of motion decreased  1  1/34 (2.94%)  1
Muscle weakness lower limb  1  2/34 (5.88%)  2
Myalgia  1  14/34 (41.18%)  28
Neck pain  1  1/34 (2.94%)  1
Pain  1  7/34 (20.59%)  12
Pain in extremity  1  2/34 (5.88%)  4
Nervous system disorders   
Concentration impairment  1  1/34 (2.94%)  1
Dizziness  1  1/34 (2.94%)  1
Dysgeusia  1  5/34 (14.71%)  6
Headache  1  3/34 (8.82%)  5
Paresthesia  1  2/34 (5.88%)  2
Peripheral sensory neuropathy  1  9/34 (26.47%)  9
Presyncope  1  2/34 (5.88%)  2
Psychiatric disorders   
Depression  1  1/34 (2.94%)  1
Insomnia  1  3/34 (8.82%)  5
Renal and urinary disorders   
Acute kidney injury  1  2/34 (5.88%)  2
Urinary incontinence  1  2/34 (5.88%)  2
Urinary tract obstruction  1  1/34 (2.94%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  1/34 (2.94%)  1
Menorrhagia  1  1/34 (2.94%)  2
Pelvic pain  1  1/34 (2.94%)  1
Reproductive system and breast disorders - (Other)  1  1/34 (2.94%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/34 (2.94%)  1
Cough  1  1/34 (2.94%)  1
Dyspnea  1  5/34 (14.71%)  7
Epistaxis  1  1/34 (2.94%)  1
Hoarseness  1  1/34 (2.94%)  1
Postnasal drip  1  1/34 (2.94%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  26/34 (76.47%)  26
Hyperhidrosis  1  1/34 (2.94%)  1
Nail discoloration  1  2/34 (5.88%)  2
Pain of skin  1  1/34 (2.94%)  1
Palmar-plantar erythrodysesthesia syndrome  1  2/34 (5.88%)  2
Pruritus  1  2/34 (5.88%)  2
Rash acneiform  1  3/34 (8.82%)  3
Rash maculo-papular  1  6/34 (17.65%)  6
Skin and subcutaneous tissue disorders - (Other)  1  1/34 (2.94%)  2
Skin hyperpigmentation  1  1/34 (2.94%)  1
Vascular disorders   
Flushing  1  4/34 (11.76%)  9
Hematoma  1  1/34 (2.94%)  1
Hot flashes  1  1/34 (2.94%)  1
Hypertension  1  2/34 (5.88%)  2
Hypotension  1  3/34 (8.82%)  4
Thromboembolic event  1  2/34 (5.88%)  2
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Overman, Associate Professor, GI Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
EMail: MOverman@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01730586    
Other Study ID Numbers: 2012-0776
NCI-2013-00077 ( Registry Identifier: NCI CTRP )
First Submitted: October 26, 2012
First Posted: November 21, 2012
Results First Submitted: May 2, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020