Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer
NCT ID: NCT01231802
Last Updated: 2012-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2011-04-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Eniluracil/5-FU/Leucovorin
Arm 1: (weekly, 28-day cycle): Approximately eighty subjects will orally self-administer eniluracil approximately 13 hr (range of 11-16 hr) before receiving 5 FU and leucovorin. The next day they will orally self-administer 5-FU and leucovorin. On the third day, they will orally self-administer leucovorin. The regimen is taken once per week for three consecutive weeks followed by one-week off-treatment.
Eniluracil
Eniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, \& 15
5-Fluorouracil
5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, \& 16
Leucovorin
Leucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, \& 17
Arm 2: Capecitabine
Arm 2: (bid daily, 21-day cycle): Approximately sixty subjects will self-administer oral capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment
Capecitabine
Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment
Interventions
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Eniluracil
Eniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, \& 15
5-Fluorouracil
5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, \& 16
Leucovorin
Leucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, \& 17
Capecitabine
Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Adherex Technologies, Inc.
INDUSTRY
Responsible Party
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Adherex Technologies, Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
The Methodist Hospital Cancer Center
Houston, Texas, United States
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, , Russia
Chelyabinsk Regional Clinical Oncology
Chelyabinsk, , Russia
Clinical Oncology Center #1
Krasnodar, , Russia
Moscow Hertzen Oncology Research Institute
Moscow, , Russia
Russian Oncological Research Center n.s. Blokhin
Moscow, , Russia
Orenburg Regional Clinical Oncology Center
Orenburg, , Russia
Pyatigorsk Oncology Center
Pyatigorsk, , Russia
Republic Oncology Center
Republic of Karelia, , Russia
City Clinical Oncology Center
Saint Petersburg, , Russia
Laboratory of Thoracic Oncology of Research Institute of Pulmonary at St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, , Russia
Leningrad Regional Oncology Center
Saint Petersburg, , Russia
Road Clinical Hospital of the Russian Railways
Saint Petersburg, , Russia
Oncology Center No. 2 Krasnodar Regional Healthcare Dept
Sochi, , Russia
Stavropol Regional Clinical Oncology Center
Stavropol, , Russia
Countries
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Central Contacts
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References
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Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Other Identifiers
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AHX-03-202
Identifier Type: -
Identifier Source: org_study_id