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Trial record 7 of 430 for:    colon cancer AND Capecitabine

Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer (SorCape)

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ClinicalTrials.gov Identifier: NCT01471353
Recruitment Status : Completed
First Posted : November 16, 2011
Results First Posted : March 30, 2017
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer Metastatic
Intervention Drug: Sorafenib Plus Capecitabine (SorCape)
Enrollment 43
Recruitment Details  
Pre-assignment Details 43 Patients were consented and enrolled; however, only 42 were dosed. The one patient that was not dosed was removed due to progression of disease prior to treatment initiation.
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
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Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Period Title: Overall Study
Started 42
Completed 39
Not Completed 3
Reason Not Completed
remain on study             3
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
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Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
Adults with metastatic colorectal cancer who had previously received two or more lines of systemic therapy.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  69.0%
>=65 years
13
  31.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
57
(36 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
9
  21.4%
Male
33
  78.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
42
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  26.2%
White
31
  73.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
1.Primary Outcome
Title Sorafenib Activity
Hide Description Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame 2 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
Hide Arm/Group Description:

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: days
123
(62 to 132)
2.Secondary Outcome
Title Overall Survival
Hide Description Evaluate overall survival after treatment.
Time Frame 5 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
Hide Arm/Group Description:

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: days
261
(132 to 370)
3.Secondary Outcome
Title Response Rate
Hide Description This is the percentage of subjects that achieved either a complete response or a partial response per RECIST 1.1 criteria
Time Frame 3 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
Hide Arm/Group Description:

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.38
(0.06 to 12.57)
4.Secondary Outcome
Title Response Duration
Hide Description This is the median response duration (median time from date of a complete or partial response to date of disease progression per RECIST 1.1 criteria) and includes only subjects that achieved either a complete or partial response to treatment per RECIST 1.1 criteria.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data are available for this outcome measure since only 1 participant achieved a partial or complete response.
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
Hide Arm/Group Description:

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Toxicity (Percentage of Subjects That Experienced an Adverse Event)
Hide Description Evaluate acute toxicity of treatment. The toxicity assessments were graded by the NCI CTCAE (Clinical Trial Common Adverse Event) grading system – a global standard for assessments of clinical and laboratory toxicities. All toxicities are scored 1(mild) through 5 (death related to the event) based upon well-defined and reproducible definitions.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
Hide Arm/Group Description:

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: percentage of participants
Adverse Events - Any Grade 100
Adverse Events - Grade 3 74
Adverse Events - Grade 4 2
6.Secondary Outcome
Title Correlative Tissue Analysis
Hide Description Exploratory tissue analysis in patients receiving sorafenib plus capecitabine
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
Hide Arm/Group Description:

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib Plus Capecitabine (SorCape)
Hide Arm/Group Description

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

All-Cause Mortality
Sorafenib Plus Capecitabine (SorCape)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib Plus Capecitabine (SorCape)
Affected / at Risk (%) # Events
Total   13/42 (30.95%)    
Blood and lymphatic system disorders   
Anemia  1  1/42 (2.38%)  1
Spleen Disorder  1  1/42 (2.38%)  1
Cardiac disorders   
Sinus Tachycardia  1  1/42 (2.38%)  1
Gastrointestinal disorders   
Abdominal Pain  1  2/42 (4.76%)  2
Colonic Obstruction  1  1/42 (2.38%)  1
Gastrointestinal Disorders - Other, Bowel Perforation  1  1/42 (2.38%)  1
General disorders   
Fatigue  1  1/42 (2.38%)  1
General Disorders and Administration Site Conditions - Other, Anasarca  1  1/42 (2.38%)  1
Non-Cardiac Chest Pain  1  2/42 (4.76%)  3
Pain  1  1/42 (2.38%)  1
Hepatobiliary disorders   
Hepatobiliary Disorders - Other, Cirrhosis  1  1/42 (2.38%)  1
Infections and infestations   
Sepsis  1  1/42 (2.38%)  1
Investigations   
Creatinine Increased  1  1/42 (2.38%)  1
Hyponatremia  1  1/42 (2.38%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/42 (4.76%)  2
Musculoskeletal and connective tissue disorders   
Generalized Muscle Weakness  1  1/42 (2.38%)  1
Nervous system disorders   
Syncope  1  1/42 (2.38%)  1
Psychiatric disorders   
Agitation  1  1/42 (2.38%)  1
Confusion  1  1/42 (2.38%)  1
Delirium  1  2/42 (4.76%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/42 (2.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sorafenib Plus Capecitabine (SorCape)
Affected / at Risk (%) # Events
Total   42/42 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/42 (2.38%)  1
Cardiac disorders   
Cardiac Disorders - Other, Ventricular Bigeminy  1  1/42 (2.38%)  1
Ear and labyrinth disorders   
Vertigo  1  1/42 (2.38%)  1
Eye disorders   
Blurred Vision  1  1/42 (2.38%)  1
Dry Eye  1  1/42 (2.38%)  1
Gastrointestinal disorders   
Abdominal Pain  1  9/42 (21.43%)  14
Bloating  1  1/42 (2.38%)  3
Constipation  1  6/42 (14.29%)  7
Diarrhea  1  16/42 (38.10%)  30
Dyspepsia  1  3/42 (7.14%)  3
Enterocolitis  1  1/42 (2.38%)  1
Flatulence  1  2/42 (4.76%)  2
Gastritis  1  2/42 (4.76%)  2
Gastroesophageal Reflux Disease  1  1/42 (2.38%)  1
Gastrointestinal Disorders - Other, Gastric Bezoar  1  1/42 (2.38%)  1
Gastrointestinal Pain  1  1/42 (2.38%)  1
Mucositis Oral  1  7/42 (16.67%)  12
Nausea  1  17/42 (40.48%)  23
Proctitis  1  1/42 (2.38%)  1
Vomiting  1  11/42 (26.19%)  12
General disorders   
Fatigue  1  25/42 (59.52%)  36
Fever  1  1/42 (2.38%)  3
Flu-Like Symptoms  1  4/42 (9.52%)  4
Localized Edema  1  1/42 (2.38%)  1
Malaise  1  2/42 (4.76%)  2
Non-Cardiac Chest Pain  1  2/42 (4.76%)  8
Pain  1  4/42 (9.52%)  9
Infections and infestations   
Anorectal Infection  1  1/42 (2.38%)  1
Infections and Infestations - Other, Cold Symptoms  1  2/42 (4.76%)  2
Mucosal Infection  1  1/42 (2.38%)  1
Pelvic Infection  1  1/42 (2.38%)  1
Splenic Infection  1  1/42 (2.38%)  1
Syncope  1  1/42 (2.38%)  1
Upper Respiratory Infection  1  3/42 (7.14%)  3
Urinary Tract Infection  1  1/42 (2.38%)  1
Weight Loss  1  9/42 (21.43%)  11
Investigations   
Aspartate Aminotransferase Increased  1  1/42 (2.38%)  1
Creatinine Increasted  1  1/42 (2.38%)  2
Hypokalemia  1  1/42 (2.38%)  1
Hyponatremia  1  2/42 (4.76%)  2
Platelet Count Decreased  1  2/42 (4.76%)  2
Metabolism and nutrition disorders   
Anorexia  1  17/42 (40.48%)  19
Dehydration  1  3/42 (7.14%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/42 (2.38%)  1
Back Pain  1  1/42 (2.38%)  2
Flank Pain  1  1/42 (2.38%)  2
Musculoskeletal and Connective Tissue Disorder - Other, Muscle Cramps  1  2/42 (4.76%)  3
Musculoskeletal and Connective Tissue Disorder - Other, Wrist Sprain  1  1/42 (2.38%)  1
Myalgia  1  1/42 (2.38%)  1
Neck Pain  1  1/42 (2.38%)  1
Nervous system disorders   
Headache  1  1/42 (2.38%)  2
Peripheral Sensory Neuropathy  1  3/42 (7.14%)  3
Presyncope  1  1/42 (2.38%)  1
Seizure  1  1/42 (2.38%)  1
Psychiatric disorders   
Anxiety  1  1/42 (2.38%)  1
Confusion  1  3/42 (7.14%)  3
Delirium  1  2/42 (4.76%)  2
Delusions  1  1/42 (2.38%)  1
Depression  1  1/42 (2.38%)  1
Insomnia  1  2/42 (4.76%)  2
Personality Change  1  1/42 (2.38%)  1
Renal and urinary disorders   
Renal Calculi  1  1/42 (2.38%)  2
Urinary Tract Obstruction  1  1/42 (2.38%)  1
Urine Discoloration  1  1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic Rhinitis  1  1/42 (2.38%)  1
Cough  1  1/42 (2.38%)  5
Dyspnea  1  4/42 (9.52%)  4
Epistaxis  1  1/42 (2.38%)  1
Hoarseness  1  2/42 (4.76%)  3
Laryngeal Hemorrhage  1  1/42 (2.38%)  1
Sore Throat  1  1/42 (2.38%)  1
Skin and subcutaneous tissue disorders   
Palmar-Plantar Erythrodysesthesia Syndrome  1  36/42 (85.71%)  126
Photosensitivity  1  3/42 (7.14%)  3
Pruritis  1  1/42 (2.38%)  2
Rash Maculo-Papular  1  4/42 (9.52%)  4
Skin and Subcutaneous Tissue Disorders - Other, Brittle Nails  1  1/42 (2.38%)  1
Vascular disorders   
Hot Flashes  1  1/42 (2.38%)  2
Hypertension  1  9/42 (21.43%)  13
Hypotension  1  1/42 (2.38%)  1
Thromboembolic Event  1  1/42 (2.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Thomas J. George, Jr.
Organization: University of Florida
Phone: 352-273-8008
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01471353     History of Changes
Other Study ID Numbers: ONC2010-23
IRB201701484 ( Other Identifier: University of Florida conversion# )
First Submitted: November 10, 2011
First Posted: November 16, 2011
Results First Submitted: November 15, 2016
Results First Posted: March 30, 2017
Last Update Posted: July 29, 2019