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Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer

Information source: Adherex Technologies, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Breast Cancer

Intervention: Eniluracil (Drug); 5-Fluorouracil (Drug); Leucovorin (Drug); Capecitabine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Adherex Technologies, Inc.

Overall contact:
Gray Kirby, PharmD, Phone: 919-614-3839, Email: kirbyg@adherex.com


The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.

Clinical Details

Official title: A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome: To compare the tolerability and toxicity of orally administered eniluracil/5 FU/leucovorin regimen vs. capecitabine monotherapy


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Histologically or cytologically confirmed metastatic (Stage IV) adenocarcinoma of the


- Prior exposure to anthracyclines either in the neoadjuvant/adjuvant setting, or as

treatment for metastatic disease

- Either evidence of a recurrence or development of metastatic disease at least 12

months after the last dose of a taxane as neoadjuvant/adjuvant therapy, or evidence of disease progression while receiving a taxane for metastatic disease

- ECOG Performance Status of 0 or 1

- Measurable disease according to RECIST 1. 1 Criteria

- Adequate renal, hematologic, and hepatic function

- Negative pregnancy test and willing to use effective contraception

- Willing to avoid any other dose or form (iv, oral, or topical) of 5 FU or related

derivatives for 8 weeks following the last dose of eniluracil

- Willing to be closely monitored for changes in coagulation parameters (prothrombin

time and/or international normalized ratio [INR] values) if receiving concomitant warfarin Exclusion Criteria:

- Pregnant or lactating females

- Prior treatment with capecitabine

- More than one prior chemotherapy regimen for metastatic disease

- Prior radiation must not have included ≥ 30% of major bone marrow-containing areas

(pelvis, lumbar spine). If prior radiation was < 30%, then a minimum interval of 6 weeks must be allowed between the last radiation treatment and administration of either study arm.

- Currently receiving anti-cancer therapy

- Residual ≥ Grade 2 clinically significant side effects (excluding alopecia)

associated with prior radiotherapy, chemotherapy, and investigational treatments

- Unstable CNS metastases. However, subjects that are asymptomatic and off systemic

steroids and anticonvulsants for at least 3 months are not excluded.

- Malabsorption syndrome, disease significantly affecting gastrointestinal function,

resection of the stomach or small bowel, ulcerative colitis, recent history of GI bleeding or perforation

- History of other malignancy, except subjects who have been disease-free for 5 years

or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma

- Concurrent disease or condition that would make the subject inappropriate for study

participation, or any serious medical disorder that would interfere with the subject's safety

- Known history or clinical evidence of leptomeningeal carcinomatosis

- Active or uncontrolled infection

- Dementia, altered mental status, or any psychiatric condition that would prohibit the

understanding or rendering of informed consent

- Known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart


- Concurrent treatment with an investigational agent

- Use of an investigational drug within 30 days or 5 half-lives, whichever is longer,

preceding the first dose of study medication

- Taking phenytoin

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs

chemically related to capecitabine, fluorouracil, leucovorin, or any excipients

- Known dihydropyrimidine dehydrogenase (DPD) deficiency

Locations and Contacts

Gray Kirby, PharmD, Phone: 919-614-3839, Email: kirbyg@adherex.com

Arkhangelsk Regional Clinical Oncology Center, Arkhangelsk 163045, Russian Federation; Recruiting

Chelyabinsk Regional Clinical Oncology, Chelyabinsk 454087, Russian Federation; Recruiting

Clinical Oncology Center #1, Krasnodar, Russian Federation; Recruiting

Leningrad Regional Oncology Center, Leningrad, Russian Federation; Recruiting

Moscow Hertzen Oncology Research Institute, Moscow, Russian Federation; Recruiting

Russian Oncological Research Center n.s. Blokhin, Moscow, Russian Federation; Recruiting

Orenburg Regional Clinical Oncology Center, Orenburg, Russian Federation; Recruiting

Pyatigorsk Oncology Center, Pyatigorsk, Russian Federation; Recruiting

Republic Oncology Center, Republic of Karelia, Russian Federation; Recruiting

Oncology Center No. 2 Krasnodar Regional Healthcare Dept, Sochi 354057, Russian Federation; Recruiting

City Clinical Oncology Center, St. Petersburg, Russian Federation; Recruiting

Laboratory of Thoracic Oncology of Research Institute of Pulmonary at St. Petersburg State Medical University n.a. I.P. Pavlov, St. Petersburg, Russian Federation; Recruiting

Road Clinical Hospital of the Russian Railways, St. Petersburg, Russian Federation; Recruiting

Stavropol Regional Clinical Oncology Center, Stavropol, Russian Federation; Recruiting

Banner MD Anderson Cancer Center, Gilbert, Arizona 85234, United States; Recruiting

The Methodist Hospital Cancer Center, Houston, Texas 77030, United States; Recruiting

Additional Information

Starting date: April 2011
Last updated: July 16, 2012

Page last updated: August 23, 2015

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