Recruiting
Phase 2

Eniluracil & 5-FU

Sponsor:

Adherex Technologies, Inc.

Code:

NCT01231802

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eniluracil

5-Fluorouracil

Leucovorin

Capecitabine

Study Details

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.

Conditions

Metastatic Breast Cancer

Study ID

NCT01231802

Start date

Apr, 2011

Status verified date

Jul, 2012

Completion date

Jan, 2013

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

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

Primary outcome measure

  • Progression-free survival [ Time Frame: 7.5 months ]

Central Contacts and Locations

Central contacts

Gray Kirby, PharmD

919-614-3839kirbyg@adherex.com

Anne McKay

919-949-2987mckaya@adherex.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

The Methodist Hospital Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Adherex Technologies, Inc.

Last update posted

Jul 17, 2012

Last verified

Jul, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Adherex Technologies, Inc. on 2012-07-17.