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

Status unconfirmed · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT01231802

Run by

Adherex Technologies, Inc.

People needed

140

Starts

2011-04-01

Expected to finish

2013-01-01

Last updated by the study team

2012-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 failure
• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• The Methodist Hospital Cancer Center — Houston, Texas, United States (enrolling)
• Arkhangelsk Regional Clinical Oncology Center — Arkhangelsk, Russia (enrolling)
• Chelyabinsk Regional Clinical Oncology — Chelyabinsk, Russia (enrolling)
• Clinical Oncology Center #1 — Krasnodar, Russia (enrolling)
• Moscow Hertzen Oncology Research Institute — Moscow, Russia (enrolling)
• Russian Oncological Research Center n.s. Blokhin — Moscow, Russia (enrolling)
• Orenburg Regional Clinical Oncology Center — Orenburg, Russia (enrolling)
• Pyatigorsk Oncology Center — Pyatigorsk, Russia (enrolling)
• Republic Oncology Center — Republic of Karelia, Russia (enrolling)
• City Clinical Oncology Center — Saint Petersburg, Russia (enrolling)
• Laboratory of Thoracic Oncology of Research Institute of Pulmonary at St. Petersburg State Medical University n.a. I.P. Pavlov — Saint Petersburg, Russia (enrolling)
• Leningrad Regional Oncology Center — Saint Petersburg, Russia (enrolling)
• Road Clinical Hospital of the Russian Railways — Saint Petersburg, Russia (enrolling)
• Oncology Center No. 2 Krasnodar Regional Healthcare Dept — Sochi, Russia (enrolling)
• Stavropol Regional Clinical Oncology Center — Stavropol, Russia (enrolling)

Full record on ClinicalTrials.gov

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