A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer

NCT ID: NCT00883116

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 551 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-02-28

Brief Summary

The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ixabepilone, 40 mg/m^2, intravenously (IV)

Participants received ixabepilone, 40 mg/m\^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression

Group Type: EXPERIMENTAL

Ixabepilone

Intervention Type: DRUG

Control chemotherapy (Paclitaxel or Doxorubicin)

Participants received either paclitaxel, 175 mg/m\^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m\^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m\^2.

Group Type: ACTIVE_COMPARATOR

Doxorubicin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Interventions

Ixabepilone

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Other Intervention Names

Ixempra; BMS-247550; Adriamycin PFS/RDF; Adriacin; Adriblastina; Adriablastine; Adrimedac; DOXO-CELL; Doxolem; Doxorubin; Farmiblastina; Rubex; Taxol; Anzatax; Asotax; Bristaxol Praxel; Taxol Konzentrat; F1-106

Eligibility Criteria

Inclusion Criteria

• Women aged 18 years and older
• Histologic or cytologic diagnosis of endometrial carcinoma
• Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation.
• Karnofsky performance status >=70
• Measurable or nonmeasurable disease that has progressed since last treatment.

• If only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology.
• Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
• All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed.
• Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.

Exclusion Criteria

• Carcinosarcoma (malignant mixed mullerian tumor)
• Endometrial leiomyosarcoma and endometrial stromal sarcomas
• Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol)
• Known brain metastases
• Receipt of prior ixabepilone therapy
• Concurrent active infection requiring antibiotics or other therapy
• Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months
• For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction <50% as measured by multigated radionuclide angiography or echocardiography
• History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
• Known human immunodeficiency viral infection
• Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
• Absolute neutrophil count <1500/mm^3
• Platelets <100,000/mm^3
• Hemoglobin <9 g/dL
• Total bilirubin >1.5*upper limit of normal (ULN), except for those with Gilbert's disease
• Aspartate aminotransferase or alanine aminotransferase >2.5*ULN
• Serum creatinine >1.5*ULN
• Grade ≥2 neuropathy (sensory or motor)
• No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

R-Pharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

University Of South Alabama

Mobile, Alabama, United States

Rocky Mountain Gynecologic Oncology

Englewood, Colorado, United States

Peter E. Schwartz, Md

New Haven, Connecticut, United States

Hematology Oncology, P.C.

Stamford, Connecticut, United States

Gynecologic Oncology Assoc.,Inc

Hollywood, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Georgia Health Science University

Augusta, Georgia, United States

Sudarshan K. Sharma, Md

Hinsdale, Illinois, United States

Central Dupage Hospital Cancer Center

Warrenville, Illinois, United States

St. Vincent Hospital And Health Care Center, Inc.

Indianapolis, Indiana, United States

Hematology And Oncology Specialists, Llc

Marrero, Louisiana, United States

Women'S Health Specialists

Rockville, Maryland, United States

Sparrow Regional Cancer Center

Lansing, Michigan, United States

University Of Minnesota

Minneapolis, Minnesota, United States

Saint Dominic's Gynecologic Oncology

Jackson, Mississippi, United States

Matthew A Powell, Md

St Louis, Missouri, United States

Blumenthal Cancer Center

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Peggy And Charles Stephenson Oklahoma Cancer Center

Oklahoma City, Oklahoma, United States

Tulsa Cancer Institute

Tulsa, Oklahoma, United States

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, United States

Magee-Womens Hospital Of Upmc Laboratory

Pittsburgh, Pennsylvania, United States

Women & Infants Hospital Of Ri

Providence, Rhode Island, United States

Cancer Centers Of The Carolinas

Greenville, South Carolina, United States

Tennessee Gynecologic Oncology Group, Llc

Chattanooga, Tennessee, United States

University Of Virginia

Charlottesville, Virginia, United States

Local Institution

La Rioja, La Rioja Province, Argentina

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Salta, Salta Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Milton, Queensland, Australia

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East Bentleigh, Victoria, Australia

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Ghent, , Belgium

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Leuven, , Belgium

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Porto Alegre, Rio Grande do Sul, Brazil

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Barretos, São Paulo, Brazil

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Jaú, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Toronto, Ontario, Canada

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Fleurimont, Quebec, Canada

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Montreal, Quebec, Canada

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Brno, , Czechia

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Hradec Králové, , Czechia

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Copenhagen, , Denmark

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Herlev, , Denmark

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Odense C, , Denmark

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Paris, , France

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Poitiers, , France

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Saint-Herblain, , France

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Villejuif, , France

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Athens, , Greece

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Budapest, , Hungary

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Miskolc, , Hungary

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Brescia, , Italy

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Campobasso, , Italy

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Meldola (fc), , Italy

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Milan, , Italy

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Monza, , Italy

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Roma, , Italy

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Guadalajara, Jalisco, Mexico

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Df, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Mexico City, Mexico

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Tlalpan, Mexico City, Mexico

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Bergen, , Norway

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Oslo, , Norway

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Ivanovo, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Obninsk, , Russia

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Saint Pertersburg, , Russia

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Saint Petersburg, , Russia

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Barcelona, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Bristol, Avon, United Kingdom

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Glasgow, Dumfries & Galloway, United Kingdom

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Nottingham, Nottinghamshire, United Kingdom

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Leeds, Yorkshire, United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Czechia; Denmark; France; Greece; Hungary; Italy; Mexico; Norway; Peru; Russia; Spain; Sweden; United Kingdom

References

McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026. Epub 2015 Apr 26.

Reference Type: DERIVED

PMID: 25925990 (View on PubMed)

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

2008-007167-16

Identifier Type: -

Identifier Source: secondary_id

CA163-196

Identifier Type: -

Identifier Source: org_study_id