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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometrial Cancer

Intervention: Ixabepilone (Drug); Doxorubicin (Drug); Paclitaxel (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

Official title: A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival (OS)

Secondary outcome:

Progression-free Survival

Best Overall Response Rate

Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Key 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. Key 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

Locations and Contacts

Local Institution, La Rioja 5300, Argentina

Local Institution, Salta A4406CLA, Argentina

Local Institution, Gent 9000, Belgium

Local Institution, Leuven B-3000, Belgium

Local Institution, Sao Paulo 01246-000, Brazil

Local Institution, Brno 656 53, Czech Republic

Local Institution, Hradec Kralove 500 05, Czech Republic

Local Institution, Copenhagen 2100, Denmark

Local Institution, Herlev 2730, Denmark

Local Institution, Odense C 5000, Denmark

Local Institution, Paris 75004, France

Local Institution, Poitiers 86000, France

Local Institution, Saint Herblain Cedex 44805, France

Local Institution, Villejuif Cedex 94800, France

Local Institution, Athens 11528, Greece

Local Institution, Budapest 1122, Hungary

Local Institution, Miskolc H-3526, Hungary

Local Institution, Brescia 25123, Italy

Local Institution, Campobasso 86100, Italy

Local Institution, Meldola (fc) 47014, Italy

Local Institution, Milano 20141, Italy

Local Institution, Monza 20052, Italy

Local Institution, Roma 00168, Italy

Local Institution, Bergen 5021, Norway

Local Institution, Oslo 0310, Norway

Local Institution, Lima Lima 11, Peru

Local Institution, Lima LIMA 13, Peru

Local Institution, Lima 34, Peru

Local Institution, Ivanovo 153013, Russian Federation

Local Institution, Moscow 115 478, Russian Federation

Local Institution, Moscow 117997, Russian Federation

Local Institution, Obninsk 249036, Russian Federation

Local Institution, St Pertersburg 198255, Russian Federation

Local Institution, St Petersburg 197758, Russian Federation

Local Institution, Barcelona 08035, Spain

Local Institution, Madrid 28040, Spain

Local Institution, Valencia 46009, Spain

Local Institution, Goteborg 413 45, Sweden

Local Institution, Linkoping 581 85, Sweden

Local Institution, Stockholm 171 76, Sweden

Local Institution, Umea 901 85, Sweden

Local Institution, Uppsala 751 85, Sweden

University Of South Alabama, Mobile, Alabama 36604, United States

Local Institution, Calgary, Alberta T2N 4N2, Canada

Local Institution, Bristol, Avon BS2 8ED, United Kingdom

Local Institution, Surrey, British Columbia V3V 1Z2, Canada

Local Institution, Vancouver, British Columbia V5Z 4E6, Canada

Rocky Mountain Gynecologic Oncology, Englewood, Colorado 80113, United States

Peter E. Schwartz, Md, New Haven, Connecticut 06510-3206, United States

Hematology Oncology, P.C., Stamford, Connecticut 06902, United States

Local Institution, Df, Distrito Federal 06720, Mexico

Local Institution, Mexico City, Distrito Federal 06726, Mexico

Local Institution, Mexico, Distrito Federal 07760, Mexico

Local Institution, Monterrey, Distrito Federal 64320, Mexico

Local Institution, Tlalpan, Distrito Federal 14080, Mexico

Local Institution, Glasgow, Dumfries & Galloway G12 0YN, United Kingdom

Gynecologic Oncology Assoc.,Inc, Hollywood, Florida 33021, United States

Florida Hospital Cancer Institute, Orlando, Florida 32804, United States

Sarasota Memorial Health Care System, Sarasota, Florida 34239, United States

H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States

Georgia Health Science University, Augusta, Georgia 30912-3335, United States

Sudarshan K. Sharma, Md, Hinsdale, Illinois 60521, United States

Central Dupage Hospital Cancer Center, Warrenville, Illinois 60555, United States

St. Vincent Hospital And Health Care Center, Inc., Indianapolis, Indiana 46260, United States

Local Institution, Guadalajara, Jalisco 44340, Mexico

Hematology And Oncology Specialists, Llc, Marrero, Louisiana 70072, United States

Women'S Health Specialists, Rockville, Maryland 20852, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48912, United States

University Of Minnesota, Minneapolis, Minnesota 55455-0374, United States

Saint Dominic's Gynecologic Oncology, Jackson, Mississippi 39216, United States

Matthew A Powell, Md, Saint Louis, Missouri 63110, United States

Blumenthal Cancer Center, Charlotte, North Carolina 28204, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Local Institution, Nottingham, Nottinghamshire NG5 1PB, United Kingdom

Local Institution, Halifax, Nova Scotia B3H 1V7, Canada

Peggy And Charles Stephenson Oklahoma Cancer Center, Oklahoma City, Oklahoma 73104, United States

Tulsa Cancer Institute, Tulsa, Oklahoma 74136, United States

Local Institution, Toronto, Ontario M5G 2M9, Canada

Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania 19106, United States

Magee-Womens Hospital Of Upmc Laboratory, Pittsburgh, Pennsylvania 15213, United States

Local Institution, Fleurimont, Quebec J1H 5N4, Canada

Local Institution, Montreal, Quebec H2L 4M1, Canada

Local Institution, Milton, Queensland 4064, Australia

Women & Infants Hospital Of Ri, Providence, Rhode Island 02908, United States

Local Institution, Porto Alegre, Rio Grande Do Sul 90610-000, Brazil

Local Institution, Rosario, Santa Fe S2000DSK, Argentina

Local Institution, Barretos, Sao Paulo 14784-400, Brazil

Local Institution, Jau, Sao Paulo 17210-120, Brazil

Cancer Centers Of The Carolinas, Greenville, South Carolina 29615, United States

Tennessee Gynecologic Oncology Group, Llc, Chattanooga, Tennessee 37403, United States

Local Institution, East Bentleigh, Victoria 3165, Australia

University Of Virginia, Charlottesville, Virginia 22908, United States

Local Institution, Leeds, Yorkshire LS9 7TF, United Kingdom

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: August 2009
Last updated: June 16, 2015

Page last updated: August 23, 2015

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