Capecitabine With Digoxin for Metastatic Breast Cancer
Information source: Western Regional Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Breast Cancer
Intervention: Capecitabine (Drug); Digoxin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Western Regional Medical Center Official(s) and/or principal investigator(s): Jiaxin Niu, MD, PhD, Principal Investigator, Affiliation: Western Regional Medical Center
Overall contact: Marci Pierog, RN, Phone: 623-207-3000, Email: clinicaltrials@ctca-hope.com
Summary
To evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine
with oral digoxin in metastatic breast cancer
Clinical Details
Official title: Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer
Secondary outcome: 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)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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. 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.
Locations and Contacts
Marci Pierog, RN, Phone: 623-207-3000, Email: clinicaltrials@ctca-hope.com
Western Regional Medical Center, Goodyear, Arizona 85338, United States; Recruiting
Additional Information
Starting date: April 2013
Last updated: June 4, 2015
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