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Capecitabine With Digoxin for Metastatic Breast 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. Identifier: NCT01887288
Recruitment Status : Terminated (PI Leaving Site)
First Posted : June 26, 2013
Results First Posted : November 8, 2017
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Western Regional Medical Center

Brief Summary:
To evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Capecitabine Drug: Digoxin Phase 2

Detailed Description:
In this phase II study, the Investigators will combine metronomic capecitabine with digoxin to treat metastatic breast cancer patients who have progressed on both anthracyclines and taxanes. We hypothesize that the combination of digoxin with metronomic capecitabine may lead to increased efficacy and duration of treatment without progression with decreased side effects than standard regimen.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment
Study Start Date : April 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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)

Drug: Capecitabine
650 mg/m^2 PO b.i.d.
Other Name: Xeloda®
Drug: Digoxin
0.25 mg once daily
Other Names:
  • Cardoxin®
  • Digitek®
  • Lanoxicaps®
  • Lanoxin®

Primary Outcome Measures :
  1. Metronomic Capecitabine With Oral Digoxin [ Time Frame: One year ]
    Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer

Secondary Outcome Measures :
  1. Combination Overall Clinical Benefit by RECIST 1.1 [ Time Frame: One year ]
    Assess the activity of this combination in terms of overall clinical benefit rates (CBR), including complete response (CR), partial response (PR) or stable disease (SD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients ≥ 18 years of age with histologically confirmed, metastatic breast cancer resistant to anthracyclines and taxanes
  2. Anthracycline resistance is defined as tumor progression during treatment or within 3 months of last dose in the metastatic setting, or recurrence within 6 months in the neoadjuvant or adjuvant setting. Alternatively, a minimum cumulative dose of anthracycline of 240 mg/m^2 (doxorubicin) or 360 mg/m^2 (epirubicin) has been reached, or there is contraindication to use anthracycline, the patient is also eligible
  3. Taxane resistance is defined as recurrence within 4 months of the last dose in the metastatic setting or within 12 months in the adjuvant setting
  4. Having progressed on anti-HER2 or hormonal therapy if they have HER2 positive or hormone-receptor positive breast cancer
  5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy >3 months.
  6. Participants must have at least one target lesion as defined by RECIST 1.1 that allows for evaluation of tumor response
  7. Absolute neutrophil count ≥ 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
  8. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
  9. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
  10. At least three (3) weeks from prior chemotherapy
  11. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.

Exclusion Criteria:

  1. Inadequate renal function with a calculated creatinine clearance less than 51 mL/min.
  2. History of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, hemodynamically significant or life threatening cardiac arrhythmia.
  3. Uncontrolled cardiac disease, congestive heart failure, angina or hypertension.
  4. Myocardial infarction or unstable angina within 2 months of treatment.
  5. Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
  6. Active clinically serious infection > CTCAE (version 4.03) Grade 2.
  7. Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  8. Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
  9. Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
  10. Serious non-healing wound, ulcer, or bone fracture.
  11. Major surgery or significant traumatic injury within 2 weeks of first study drug.
  12. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
  13. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
  14. Currently on anti-coagulation therapy with Coumadin, and cannot be switched other forms of anti-coagulation.
  15. Patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid within the past two weeks.
  16. Patients receiving any other investigational agents. Pregnant or Lactating females.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01887288

United States, Arizona
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Principal Investigator: Jiaxin Niu, MD, PhD Western Regional Medical Center

Responsible Party: Western Regional Medical Center Identifier: NCT01887288     History of Changes
Other Study ID Numbers: WRMC 13-05
First Posted: June 26, 2013    Key Record Dates
Results First Posted: November 8, 2017
Last Update Posted: February 22, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents
Physiological Effects of Drugs