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

This study is currently recruiting participants. (see Contacts and Locations)
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

June 24, 2013
June 24, 2013
April 2013
April 2014   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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)
Same as current
Not Provided
Not Provided
 
Capecitabine With Digoxin for Met Breast Cancer
Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Capecitabine
    Other Name: Xeloda®
  • Drug: Digoxin
    Other Names:
    • Cardoxin®
    • Digitek®
    • Lanoxicaps®
    • Lanoxin®
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
Interventions:
  • Drug: Capecitabine
  • Drug: Digoxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
April 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marci Pierog, RN 623-207-3000 clinicaltrials@ctca-hope.com
Contact: India Hill, CCRP 623-207-3000 clinicaltrials@ctca-hope.com
United States
 
NCT01887288
WRMC 13-05
No
Jiaxin Niu, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Jiaxin Niu, MD, PhD Western Regional Medical Center
Western Regional Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP