Capecitabine With Digoxin for Metastatic Breast Cancer

NCT01887288 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: WRMC 13-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Metronomic Capecitabine With Oral Digoxin

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

  One year

Secondary Outcomes (1)

• Combination Overall Clinical Benefit by RECIST 1.1

  One year

Study Arms (1)

Capecitabine with Digoxin

EXPERIMENTAL

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; Drug: Digoxin

Interventions

Capecitabine DRUG

650 mg/m\^2 PO b.i.d.

Also known as: Xeloda®

Capecitabine with Digoxin

Digoxin DRUG

0.25 mg once daily

Also known as: Cardoxin®, Digitek®, Lanoxicaps®, Lanoxin®

Capecitabine with Digoxin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age with histologically confirmed, metastatic breast cancer resistant to anthracyclines and taxanes
• 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
• 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
• Having progressed on anti-HER2 or hormonal therapy if they have HER2 positive or hormone-receptor positive breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy \>3 months.
• Participants must have at least one target lesion as defined by RECIST 1.1 that allows for evaluation of tumor response
• Absolute neutrophil count ≥ 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
• 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
• No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
• At least three (3) weeks from prior chemotherapy
• 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.

You may not qualify if:

• Inadequate renal function with a calculated creatinine clearance less than 51 mL/min.
• History of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, hemodynamically significant or life threatening cardiac arrhythmia.
• Uncontrolled cardiac disease, congestive heart failure, angina or hypertension.
• Myocardial infarction or unstable angina within 2 months of treatment.
• 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).
• Active clinically serious infection \> CTCAE (version 4.03) Grade 2.
• Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Major surgery or significant traumatic injury within 2 weeks of first study drug.
• Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
• Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
• Currently on anti-coagulation therapy with Coumadin, and cannot be switched other forms of anti-coagulation.
• Patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid within the past two weeks.

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Digoxin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: Jessica L. Coats
• Organization: CTCA

jessica.coats@ctca-hope.com

6232073899

Study Officials

• Jiaxin Niu, MD, PhD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 22, 2018
• Results First Posted: November 8, 2017

Record last verified: 2018-01

Locations

US (1)