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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Adherex Technologies, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01231802
First received: October 27, 2010
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Eniluracil
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Adherex Technologies, Inc.:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the tolerability and toxicity of orally administered eniluracil/5 FU/leucovorin regimen vs. capecitabine monotherapy [ Time Frame: 7.5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: April 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Eniluracil
Eniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, & 15
Drug: 5-Fluorouracil
5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, & 16
Drug: Leucovorin
Leucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, & 17
Active Comparator: 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
Drug: Capecitabine
Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231802

Contacts
Contact: Gray Kirby, PharmD 919-614-3839 kirbyg@adherex.com
Contact: Anne McKay 919-949-2987 mckaya@adherex.com

Locations
United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
United States, Texas
The Methodist Hospital Cancer Center Recruiting
Houston, Texas, United States, 77030
Russian Federation
Arkhangelsk Regional Clinical Oncology Center Recruiting
Arkhangelsk, Russian Federation, 163045
Chelyabinsk Regional Clinical Oncology Recruiting
Chelyabinsk, Russian Federation, 454087
Clinical Oncology Center #1 Recruiting
Krasnodar, Russian Federation
Leningrad Regional Oncology Center Recruiting
Leningrad, Russian Federation
Moscow Hertzen Oncology Research Institute Recruiting
Moscow, Russian Federation
Russian Oncological Research Center n.s. Blokhin Recruiting
Moscow, Russian Federation
Orenburg Regional Clinical Oncology Center Recruiting
Orenburg, Russian Federation
Pyatigorsk Oncology Center Recruiting
Pyatigorsk, Russian Federation
Republic Oncology Center Recruiting
Republic of Karelia, Russian Federation
Oncology Center No. 2 Krasnodar Regional Healthcare Dept Recruiting
Sochi, Russian Federation, 354057
City Clinical Oncology Center Recruiting
St. Petersburg, Russian Federation
Laboratory of Thoracic Oncology of Research Institute of Pulmonary at St. Petersburg State Medical University n.a. I.P. Pavlov Recruiting
St. Petersburg, Russian Federation
Road Clinical Hospital of the Russian Railways Recruiting
St. Petersburg, Russian Federation
Stavropol Regional Clinical Oncology Center Recruiting
Stavropol, Russian Federation
Sponsors and Collaborators
Adherex Technologies, Inc.
  More Information

No publications provided

Responsible Party: Gray Kirby/Clinical Project Manager, Adherex Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01231802     History of Changes
Other Study ID Numbers: AHX-03-202
Study First Received: October 27, 2010
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorouracil
Capecitabine
Leucovorin
Levoleucovorin
5-ethynyluracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014