Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 435 for:    colon cancer AND Capecitabine AND colon cancer

Sunitinib and Capecitabine for First Line Colon Cancer

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: NCT00961571
Recruitment Status : Terminated (Unanticipated side effects and futility)
First Posted : August 19, 2009
Results First Posted : April 21, 2017
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ruth He, Georgetown University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Intervention Drug: sunitinib and capecitabine
Enrollment 50
Recruitment Details From 2007 to 2008, we treated patients with unresectable advanced colorectal cancer with Sunitnib 37.5 mg orally once daily and Capecitabine 1000 mg orally twice daily in a phase II clinical trial at Georgetown University Hospital
Pre-assignment Details  
Arm/Group Title Sunitinib and Cepecitabine
Hide Arm/Group Description

Administration of sunitinib and capecitabine

sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

Period Title: Overall Study
Started 50
Completed 11 [1]
Not Completed 39
Reason Not Completed
Physician Decision             39
[1]
high percentage of patient drop-off study prior cancer progression
Arm/Group Title Sunitinib and Cepecitabine
Hide Arm/Group Description

Administration of sunitinib and capecitabine

sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
metastatic colon cancer who has not received 1st line systemic chemotherapy
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  45.5%
>=65 years
6
  54.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
67
(23 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
5
  45.5%
Male
6
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Arm/Group Title Sunitinib and Cepecitabine
Hide Arm/Group Description:

Administration of sunitinib and capecitabine

sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: months
18.35
(7.57 to 31.57)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib and Cepecitabine
Hide Arm/Group Description

Administration of sunitinib and capecitabine

sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

All-Cause Mortality
Sunitinib and Cepecitabine
Affected / at Risk (%)
Total   1/11 (9.09%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib and Cepecitabine
Affected / at Risk (%)
Total   8/11 (72.73%) 
Blood and lymphatic system disorders   
Lymphopenia   1/11 (9.09%) 
Neutrophils/granulocytes (ANC/AGC)   3/11 (27.27%) 
Gastrointestinal disorders   
Gastrointestinal - Other   1/11 (9.09%) 
GI Obstruction   2/11 (18.18%) 
General disorders   
Fatigue   1/11 (9.09%) 
Febrile neutropenia   1/11 (9.09%) 
Nausea   1/11 (9.09%) 
Hepatobiliary disorders   
Hypoalbuminemia   5/11 (45.45%) 
Nervous system disorders   
Neuropathy   1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other   1/11 (9.09%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib and Cepecitabine
Affected / at Risk (%)
Total   11/11 (100.00%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow - Other   1/11 (9.09%) 
Hemoglobin   6/11 (54.55%) 
Hemorrhage, CNS   1/11 (9.09%) 
Hemorrhage, GU::Urinary   1/11 (9.09%) 
Hemorrhage/Bleeding - Other   1/11 (9.09%) 
Leukocytes (total WBC)   10/11 (90.91%) 
Lymphopenia   3/11 (27.27%) 
Hypermagnesemia   1/11 (9.09%) 
Neutrophils/granulocytes (ANC/AGC)   7/11 (63.64%) 
Platelets   4/11 (36.36%) 
Hypokalemia   1/11 (9.09%) 
Thrombotic microangiopathy   1/11 (9.09%) 
Endocrine disorders   
Hyperglycemia   2/11 (18.18%) 
Gastrointestinal disorders   
Alkaline phosphatase   3/11 (27.27%) 
Anorexia   4/11 (36.36%) 
Colitis   1/11 (9.09%) 
Constipation   3/11 (27.27%) 
Diarrhea   3/11 (27.27%) 
Gastrointestinal - Other   1/11 (9.09%) 
Hemorrhage, GI::Abdomen   1/11 (9.09%) 
General disorders   
Bruising   1/11 (9.09%) 
Dehydration   1/11 (9.09%) 
Dry Lips   1/11 (9.09%) 
Dysphagia (difficulty swallowing)   1/11 (9.09%) 
Edema: limb   1/11 (9.09%) 
Fatigue (asthenia, lethargy, malaise)   5/11 (45.45%) 
Hematoma   1/11 (9.09%) 
Mucositis/stomatitis   2/11 (18.18%) 
Nausea   5/11 (45.45%) 
Pain - Other   2/11 (18.18%) 
Pain::Abdomen   3/11 (27.27%) 
Pain::Back   1/11 (9.09%) 
Rash/desquamation   1/11 (9.09%) 
Sweating (diaphoresis)   1/11 (9.09%) 
Taste alteration (dysgeusia)   2/11 (18.18%) 
Tremor   1/11 (9.09%) 
Weight loss   3/11 (27.27%) 
Hepatobiliary disorders   
ALT, SGPT (serum glutamic pyruvic transaminase)   2/11 (18.18%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)   4/11 (36.36%) 
Hepatobiliary/Pancreas - Other   1/11 (9.09%) 
Nervous system disorders   
Neurology - Other   1/11 (9.09%) 
Neuropathy: sensory   3/11 (27.27%) 
Renal and urinary disorders   
Pain::Urethra   1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Cough   2/11 (18.18%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other   1/11 (9.09%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Aiwu Ruth He
Organization: Georgetown University, Department of Medicine and Oncology
Phone: 202-444-8642
EMail: arh29@georgetown.edu
Layout table for additonal information
Responsible Party: Ruth He, Georgetown University
ClinicalTrials.gov Identifier: NCT00961571     History of Changes
Other Study ID Numbers: GA61822D
2008-308 ( Other Identifier: IRB )
First Submitted: August 18, 2009
First Posted: August 19, 2009
Results First Submitted: March 11, 2017
Results First Posted: April 21, 2017
Last Update Posted: April 3, 2018