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Trial record 1 of 1 for:    Metronomic Capecitabine with Digoxin
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Capecitabine With Digoxin for Metastatic Breast Cancer

This study has been terminated.
(PI Leaving Site)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887288
First Posted: June 26, 2013
Last Update Posted: November 8, 2017
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.
Information provided by (Responsible Party):
Western Regional Medical Center
Results First Submitted: October 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Capecitabine
Drug: Digoxin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Capecitabine With Digoxin

Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle

(1 cycle - 4 weeks)

Capecitabine: 650 mg/m^2 PO b.i.d.

Digoxin: 0.25 mg once daily


Participant Flow:   Overall Study
    Capecitabine With Digoxin
STARTED   0 
COMPLETED   0 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Capecitabine With Digoxin

Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle

(1 cycle - 4 weeks)

Capecitabine: 650 mg/m^2 PO b.i.d.

Digoxin: 0.25 mg once daily


Baseline Measures
   Capecitabine With Digoxin 
Overall Participants Analyzed 
[Units: Participants]
 0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Evaluate the GMI of the Combination of Metronomic Capecitabine With Oral Digoxin in Metastatic Breast Cancer   [ Time Frame: One year ]

2.  Secondary:   Assess the Activity of This Combination in Terms of Overall Clinical Benefit Rates as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jessica L. Coats
Organization: CTCA
phone: 6232073899
e-mail: jessica.coats@ctca-hope.com



Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01887288     History of Changes
Other Study ID Numbers: WRMC 13-05
First Submitted: June 24, 2013
First Posted: June 26, 2013
Results First Submitted: October 10, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017