Status:
UNKNOWN
Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer
Lead Sponsor:
Adherex Technologies, Inc.
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01231802
Start Date
April 1 2011
End Date
January 1 2013
Last Update
July 17 2012
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
The Methodist Hospital Cancer Center
Houston, Texas, United States, 77030
3
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, Russia, 163045
4
Chelyabinsk Regional Clinical Oncology
Chelyabinsk, Russia, 454087