Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082433
• Other study ID #: CA163-048
• Status: Completed
• Phase: Phase 3
• Start date: November 2003
• Est. completion date: March 2008

Study information

• Verified date: October 2020
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1221
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).

• Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.

• Patients may not have any history of brain and/or leptomeningeal metastases.

• Patients may not have Grade 2 or worse neuropathy at the time of study entry.

• Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer

Intervention

Drug:
• Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
• Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Locations

Country	Name	City	State
Argentina	Local Institution	Avelianeda	Buenos Aires
Argentina	Local Institution	Bahia Blanca	Buenos Aires
Argentina	Local Institution	Barrio Alto Verde	Cordoba
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma De Buenos Aires	Buenos Aires
Argentina	Local Institution	Escobar	Buenos Aires
Argentina	Local Institution	Mendoza
Argentina	Local Institution	Resistencia	Chaco
Argentina	Local Institution	Salta
Argentina	Local Institution	San Miguel De Tucuman	Tucuman
Argentina	Local Institution	Santa Fe
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Brisbane	Queensland
Australia	Local Institution	East Melbourne	Victoria
Australia	Local Institution	Herston	Queensland
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	Perth	Western Australia
Australia	Local Institution	South Brisbane	Queensland
Australia	Local Institution	Sydney	New South Wales
Australia	Local Institution	Toowoomba	Queensland
Australia	Local Institution	Westmead	New South Wales
Australia	Local Institution	Woodville	South Australia
Austria	Local Institution	Graz
Austria	Local Institution	Voecklabruck
Austria	Local Institution	Wien
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Charleroi
Belgium	Local Institution	Gent
Belgium	Local Institution	Hasselt
Belgium	Local Institution	Kortrijk
Belgium	Local Institution	Wilrijk
Brazil	Local Institution	Bela Vista	Sao Paulo
Brazil	Local Institution	Centro-Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Higienopolis	Sao Paulo
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Sao Paulo	Sp
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Thunder Bay	Ontario
Chile	Local Institution	Santiago	Metropolitana
China	Local Institution	Beijing	Beijing
China	Local Institution	Dalian	Liaoning
China	Local Institution	Dilian	Liaoning
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Jinan	Shandong
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Xi'An	Shanxi
Croatia	Local Institution	Split
Croatia	Local Institution	Zagreb
Czechia	Local Institution	Brno
Czechia	Local Institution	Hradec Kralove
Czechia	Local Institution	Prague
Czechia	Local Institution	Prague 5
Denmark	Local Institution	Aalborg
Denmark	Local Institution	Herlev
Denmark	Local Institution	Kobenhavn O
France	Local Institution	Angers
France	Local Institution	Bordeaux
France	Local Institution	Caen
France	Local Institution	Clermont-Ferrand
France	Local Institution	Colmar
France	Local Institution	Le Mans
France	Local Institution	Metz
France	Local Institution	Paris Cedex 13
France	Local Institution	Pierre Benite
France	Local Institution	Reims
France	Local Institution	Saint Brieuc
France	Local Institution	Saint Gregoire
France	Local Institution	Saint Herblain
France	Local Institution	Tours Cedex
France	Local Institution	Villejuif Cedex
Germany	Local Institution	Berlin
Germany	Local Institution	Erlangen
Germany	Local Institution	Essen
Germany	Local Institution	Hannover
Germany	Local Institution	Karlsruhe
Germany	Local Institution	Kiel
Germany	Local Institution	Marburg
Germany	Local Institution	Munchen
Germany	Local Institution	Rehling
Germany	Local Institution	Saarbrucken
Germany	Local Institution	Tubingen
Germany	Local Institution	Ulm
Germany	Local Institution	Wiesbaden
Greece	Local Institution	Athens
Greece	Local Institution	Crete
Greece	Local Institution	Patras
Greece	Local Institution	Thessaloniki
Ireland	Local Institution	Cork
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin 8
Ireland	Local Institution	Dublin 9
Ireland	Local Institution	Galway
Ireland	Local Institution	Wilton	Cork
Israel	Local Institution	Haifa
Israel	Local Institution	Jerusalem
Israel	Local Institution	Ramat-Gan
Israel	Local Institution	Tel Aviv
Italy	Local Institution	Bari
Italy	Local Institution	Firenze
Italy	Local Institution	Genova
Italy	Local Institution	Milano
Italy	Local Institution	Modena
Italy	Local Institution	Perugia
Italy	Local Institution	Potenza
Italy	Local Institution	Roma
Italy	Local Institution	Rozzano	Milan
Italy	Local Institution	San Giovanni Rotondo
Italy	Local Institution	Sora
Italy	Local Institution	Torino
Korea, Republic of	Local Institution	Gyeonggi-Do
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Netherlands	Local Institution	Arnhem
Netherlands	Local Institution	Den Haag
Netherlands	Local Institution	Enschede
Netherlands	Local Institution	Zwolle
Portugal	Local Institution	Coimbra
Portugal	Local Institution	Lisboa
Russian Federation	Local Institution	Kazan
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St. Petersburg
Singapore	Local Institution	Singapore
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Panorama	Western Cape
South Africa	Local Institution	Port Elizabeth	Eastern Cape
South Africa	Local Institution	Pretoria	Gauteng
Spain	Local Institution	Barcelona
Spain	Local Institution	Cadiz
Spain	Local Institution	Cordoba
Spain	Local Institution	Elche (Alicante)
Spain	Local Institution	Hospitalet De Llobregat
Spain	Local Institution	Jaen
Spain	Local Institution	Madrid
Spain	Local Institution	Pontevedra
Spain	Local Institution	Reus
Spain	Local Institution	Salamanca
Spain	Local Institution	Sevilla
Spain	Local Institution	Tenerife
Spain	Local Institution	Terassa	Barcelona
Spain	Local Institution	Valencia
Spain	Local Institution	Zaragoza
Switzerland	Local Institution	Bern
Switzerland	Local Institution	Thun
Switzerland	Local Institution	Zurich
Taiwan	Local Institution	Taipei
Turkey	Local Institution	Ankara
Turkey	Local Institution	Istanbul
Turkey	Local Institution	Izmir
United Kingdom	Local Institution	Belfast	Armagh
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Glasgow	Central
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Shrewsbury	Shropshire
United States	Local Institution	Albuquerque	New Mexico
United States	Local Institution	Baton Rouge	Louisiana
United States	Local Institution	Bethesda	Maryland
United States	Local Institution	Beverly Hills	California
United States	Local Institution	Boise	Idaho
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Bronx	New York
United States	Local Institution	Canton	Ohio
United States	Local Institution	Charlottesville	Virginia
United States	Local Institution	Columbia	Missouri
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Corona	California
United States	Local Institution	Dallas	Texas
United States	Local Institution	Durham	North Carolina
United States	Local Institution	Evanston	Illinois
United States	Local Institution	Goldsboro	North Carolina
United States	Local Institution	Hartford	Connecticut
United States	Local Institution	Hickory	North Carolina
United States	Local Institution	Iowa City	Iowa
United States	Local Institution	Jackson	Mississippi
United States	Local Institution	Kinston	North Carolina
United States	Local Institution	Knoxville	Tennessee
United States	Local Institution	Langhorne	Pennsylvania
United States	Local Institution	Latham	New York
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Marshfield	Wisconsin
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	Mineola	New York
United States	Local Institution	New York	New York
United States	Local Institution	Norfolk	Virginia
United States	Local Institution	Plantation	Florida
United States	Local Institution	Richmond	Virginia
United States	Local Institution	Tucson	Arizona
United States	Local Institution	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.	from date of randomization until death
Secondary	Progression-Free Survival (PFS)	PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.	every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary	Response Rate (RR)	RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants	every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary	Duration of Response	Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.	every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary	Time to Response	Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).	every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary	Treatment-Related Safety Summary	Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0	safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Secondary	Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)	Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.	Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment