Capecitabine With Digoxin for Met Breast Cancer

This study is currently recruiting participants.
Verified June 2013 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Jiaxin Niu, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01887288
First received: June 24, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Capecitabine
Drug: Digoxin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer [ Time Frame: One year ] [ Designated as safety issue: No ]
    Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 35
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Capecitabine
Other Name: Xeloda®
Drug: Digoxin
Other Names:
  • Cardoxin®
  • Digitek®
  • Lanoxicaps®
  • Lanoxin®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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. At least four (4) weeks from prior major surgery
  12. Willingness to participate in collection of pharmacokinetic samples during cycle 1 of the study
  13. Willingness to provide permission to access archived tumor samples and blood samples
  14. 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, open biopsy or significant traumatic injury within 4 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.
  16. Patients receiving any other investigational agents. Pregnant or Lactating females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887288

Contacts
Contact: Marci Pierog, RN 623-207-3000 clinicaltrials@ctca-hope.com
Contact: India Hill, CCRP 623-207-3000 clinicaltrials@ctca-hope.com

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

No publications provided

Responsible Party: Jiaxin Niu, MD, PhD, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01887288     History of Changes
Other Study ID Numbers: WRMC 13-05
Study First Received: June 24, 2013
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Digoxin
Capecitabine
Fluorouracil
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 14, 2014