Metastatic Breast CancerPhase 2NCT01231802
Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer
A Phase 2 study testing Eniluracil, 5-Fluorouracil and Leucovorin in people with Metastatic Breast Cancer, run by Adherex Technologies, Inc. at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Eniluracil, 5-Fluorouracil and Leucovorin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Apr 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Russia14 sites, 14 recruiting
- Recruiting
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, 163045
- Recruiting
Chelyabinsk Regional Clinical Oncology
Chelyabinsk, 454087
- Recruiting
Clinical Oncology Center #1
Krasnodar
- Recruiting
Moscow Hertzen Oncology Research Institute
Moscow
- Recruiting
Russian Oncological Research Center n.s. Blokhin
Moscow
- Recruiting
Orenburg Regional Clinical Oncology Center
Orenburg
- Recruiting
Pyatigorsk Oncology Center
Pyatigorsk
- Recruiting
Republic Oncology Center
Republic of Karelia
- Recruiting
City Clinical Oncology Center
Saint Petersburg
- Recruiting
Laboratory of Thoracic Oncology of Research Institute of Pulmonary at St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg
- Recruiting
Leningrad Regional Oncology Center
Saint Petersburg
- Recruiting
Road Clinical Hospital of the Russian Railways
Saint Petersburg
- Recruiting
Oncology Center No. 2 Krasnodar Regional Healthcare Dept
Sochi, 354057
- Recruiting
Stavropol Regional Clinical Oncology Center
Stavropol
United States2 sites, 2 recruiting
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
The Methodist Hospital Cancer Center
Houston, Texas, 77030
About this study
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
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
- Being tested
- Eniluracil, 5-Fluorouracil, Leucovorin, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EniluracilDrug
Eniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, \& 15
5-FluorouracilDrug
5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, \& 16
LeucovorinDrug
Leucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, \& 17
CapecitabineDrug
Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Eniluracil/5-FU/Leucovorin | Experimental | 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. Receives: Drug: Eniluracil; Drug: 5-Fluorouracil; Drug: Leucovorin |
| Arm 2: Capecitabine | Active comparator | 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 Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 7.5 months
Secondary outcomes (1)
To compare the tolerability and toxicity of orally administered eniluracil/5 FU/leucovorin regimen vs. capecitabine monotherapy
Measured: 7.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionAug 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adherex Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231802
- Sponsor's protocol ID
- AHX-03-202
- Status last verified
- Jul 2012
- First submitted
- 27 Oct 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34037241
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01231802
- Acronym / sponsor ID
- AHX-03-202
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Adherex Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Eniluracil/5-FU/Leucovorin | Experimental | Drug: Eniluracil, Drug: 5-Fluorouracil, Drug: LeucovorinArm 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. |
| Arm 2: Capecitabine | Active comparator | Drug: CapecitabineArm 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EniluracilEniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, \& 15 | Drug | Arm 1: Eniluracil/5-FU/Leucovorin |
| 5-Fluorouracil5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, \& 16 | Drug | Arm 1: Eniluracil/5-FU/Leucovorin |
| LeucovorinLeucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, \& 17 | Drug | Arm 1: Eniluracil/5-FU/Leucovorin |
| CapecitabineCapecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment | Drug | Arm 2: Capecitabine |
Primary outcome
Progression-free survival
Time frame: 7.5 months
1 secondary outcome
To compare the tolerability and toxicity of orally administered eniluracil/5 FU/leucovorin regimen vs. capecitabine monotherapy
Time frame: 7.5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Derived from this study: PubMed 34037241Hoon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eniluracil, 5-Fluorouracil and Leucovorin in people with Metastatic Breast Cancer, run by Adherex Technologies, Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Russia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gray Kirby, PharmD (919-614-3839, kirbyg@adherex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 7.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.