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Trial record 69 of 435 for:    colon cancer AND Capecitabine

Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00305643
Recruitment Status : Terminated (Terminated due to low accrual. No data analyzed.)
First Posted : March 22, 2006
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Colorectal Cancer
Pain
Interventions Drug: Capecitabine
Drug: Celecoxib
Procedure: Radiation Therapy
Drug: Placebo
Enrollment 11
Recruitment Details Recruitment Period: February 27, 2006 to October 06, 2008 from various medical clinics and institutions representing the Community Clinical Oncology Program (CCOP).
Pre-assignment Details Study terminated due to slow accrual.
Arm/Group Title Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine
Hide Arm/Group Description Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day). Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
Period Title: Overall Study
Started 6 5
Completed 6 5
Not Completed 0 0
Arm/Group Title Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine Total
Hide Arm/Group Description Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day). Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day). Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
61
(47 to 76)
66
(50 to 83)
63
(47 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
5
  83.3%
2
  40.0%
7
  63.6%
Male
1
  16.7%
3
  60.0%
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
United States 5 5 10
Puerto Rico 1 0 1
1.Primary Outcome
Title Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.
Hide Description The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of > grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.
Time Frame At 16 Weeks, with evaluations and blood test every 3 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis could be performed due to low accrual and no participants reaching the 16 week mark.
Arm/Group Title Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine
Hide Arm/Group Description:
Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.
Hide Description A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of > grade 1 HFS by 16 weeks from the commencement of therapy.
Time Frame At 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis could be performed due to low accrual and no participants reaching the 16 week mark.
Arm/Group Title Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine
Hide Arm/Group Description:
Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine
Hide Arm/Group Description Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day). Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
All-Cause Mortality
Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/5 (20.00%)    
Cardiac disorders     
Cardiac Ischemia  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I: Celecoxib + Capecitabine Arm II: Placebo + Capecitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      5/5 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin  1  2/6 (33.33%)  2 2/5 (40.00%)  2
Platelets  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Edema  1  1/6 (16.67%)  1 0/5 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal - Other  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Diarrhea  1  3/6 (50.00%)  3 0/5 (0.00%)  0
Mucositis  1 [1]  0/6 (0.00%)  0 1/5 (20.00%)  1
General disorders     
Fatigue  1  4/6 (66.67%)  4 1/5 (20.00%)  1
Pain - Other  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Metabolism and nutrition disorders     
Alkaline Phosphatase  1  1/6 (16.67%)  1 0/5 (0.00%)  0
Creatinine  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Lab - Other  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/6 (16.67%)  1 0/5 (0.00%)  0
Lumbar Spine Range of Mobility Decrease  1  0/6 (0.00%)  0 2/5 (40.00%)  2
Pain - Back  1  1/6 (16.67%)  1 0/5 (0.00%)  0
Pain - Limb  1  2/6 (33.33%)  2 0/5 (0.00%)  0
Nervous system disorders     
Neuropathy - Motor  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Neuropathy - Sensory  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Renal and urinary disorders     
Renal - Other  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/6 (16.67%)  1 0/5 (0.00%)  0
Pleural Effusion  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders     
Acne  1  1/6 (16.67%)  1 1/5 (20.00%)  1
Hand-foot  1  1/6 (16.67%)  1 3/5 (60.00%)  3
Rash  1  1/6 (16.67%)  1 0/5 (0.00%)  0
Vascular disorders     
Thrombosis  1  0/6 (0.00%)  0 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Mucositis (clinical exam) - Oral cavity
Due to low accrual in this trial, no outcome measures were evaluable.
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: Scott Kopetz, MD, PHD / Assistant Professor
Organization: UT MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00305643     History of Changes
Other Study ID Numbers: 2005-0328
MDA-CCC-0326 ( Other Identifier: NCI )
MDA-2005-0328 ( Other Identifier: NCI )
CDR0000458042 ( Registry Identifier: NCI )
First Submitted: March 21, 2006
First Posted: March 22, 2006
Results First Submitted: January 25, 2012
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015