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

PHASE2UnknownINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

January 31, 2013

Conditions
Metastatic Breast Cancer
Interventions
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

DRUG

Capecitabine

Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment

Trial Locations (16)

77030

RECRUITING

The Methodist Hospital Cancer Center, Houston

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

163045

RECRUITING

Arkhangelsk Regional Clinical Oncology Center, Arkhangelsk

354057

RECRUITING

Oncology Center No. 2 Krasnodar Regional Healthcare Dept, Sochi

454087

RECRUITING

Chelyabinsk Regional Clinical Oncology, Chelyabinsk

Unknown

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

Stavropol Regional Clinical Oncology Center, Stavropol

Sponsors
All Listed Sponsors
lead

Adherex Technologies, Inc.

INDUSTRY

NCT01231802 - Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter