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Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer


OBJECTIVES:

Primary

- To determine the effect on percent with a 50% decrease in prostate specific antigen
(PSA) response in patients with metastatic prostate cancer who have progressed on
androgen ablation therapy and are classified into 1 of 3 separate categories:

- Never received prior chemotherapy/cytotoxic therapy

- Received prior taxane-based regimen

- Received 2 prior cytotoxic chemotherapy regimens (including, but not limited to,
prior taxane and anthracyclines)

Secondary

- Determine measurable disease response in patients with measurable disease treated with
this drug and overall response rate.

- Determine the toxic effects of this drug in these patients.

- Determine the duration of PSA and measurable disease response in patients treated with
this drug.

- Determine the expression of p53, multidrug resistance protein, and Bcl-2 by
immunohistochemistry in the primary tumors of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).

Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

ACTUAL ACCRUAL: A total of 124 patients (39 for the no prior chemotherapy stratum; 49 for
the prior taxane stratum; 36 for the 2 prior cytotoxic chemotherapy regimens) were accrued
for this study.


Inclusion Criteria:



- Histologically confirmed adenocarcinoma of the prostate

- Evidence of progressive metastatic disease OR metastatic disease and rising PSA
within 4 weeks prior to registration

- Patients with bone metastases only (i.e., lacking soft tissue disease) must have
a PSA level > 10 ng/mL within a week of registration

- Patients with soft tissue metastasis and/or visceral disease must have
measurable disease OR a PSA level > 10 ng/mL within a week prior to registration

- Patients with stable metastatic disease and rising PSA must show 2 consecutive
rises in PSA measurements taken at least 2 weeks apart; most recent PSA level
must be obtained within 4 weeks of registration

- Failed prior bilateral orchiectomy or other primary hormonal therapy

- Patients who have not undergone bilateral orchiectomy must continue on
luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide
or goserelin) or LHRH antagonist (e.g., abarelix) during study treatment

- Patients without an orchiectomy must have a serum testosterone level < 50 ng/dL
within 4 weeks of registration to confirm androgen suppression

- No carcinomatous meningitis or brain metastases

- At least 4 weeks since prior flutamide AND continued evidence of progressive disease

- At least 6 weeks since prior bicalutamide or nilutamide AND continued evidence of
progressive disease

- Depending on the strata, no more than 2 prior cytotoxic chemotherapy regimens for
hormone-refractory disease with a taxane-based regimen, mitoxantrone, or another
cytotoxic chemotherapy regimen provided there is evidence of progressive disease

- Up to 1 prior experimental (non-cytotoxic) therapy AND evidence of progressive
disease

- Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed provided
treatment was initiated at least 4 weeks ago and there is evidence of progressive
disease

- At least 4 weeks since prior estrogen or estrogen-like agents, or other hormonal
therapy AND disease progression needs to be confirmed by a rising PSA after the
required 4-week washout period

- Adequate bone marrow function

- Serum glutamic-pyruvic transaminase (SGPT) < 2 times the institutional upper limit of
normal

- Bilirubin < 1.5 mg/dL

- Creatinine < 1.5 mg/dL OR a calculated creatinine clearance ≥ 50 mL/min

- Normal international normalized ratio (INR)

- Patients must have electrocardiography (ECG) within 4 weeks of registration

- Patients with a history of prior malignancy are eligible provided they have been
treated with curative intent and free of disease for > 5 years (excluding
non-melanomatous skin cancers treated with curative intent)

- Fertile patients must use effective contraception

- All sites of disease must have been evaluated within 4 weeks of registration

- Age 18 or older

- ECOG performance status (PS) of 0-2

Exclusion Criteria:

- Prior radiotherapy < 4 weeks prior to registration

- Prior Strontium 89, Samarium 153, or other radioisotope

- Concurrent estrogen or estrogen-like agents or any other hormonal therapy

- Active angina pectoris

- New York Heart Association class III-IV heart disease

- Myocardial infarction within 6 months prior to registration

- Evidence of ventricular dysrhythmias or unstable arrhythmia

- Carcinomatous meningitis or brain metastases.

- Peripheral neuropathy > grade 1

- Serious medical illness or active infection that would preclude study participation

- Concurrent investigational agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Patients With PSA Response

Outcome Description:

PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.

Outcome Time Frame:

Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry

Safety Issue:

No

Principal Investigator

Glenn Liu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00548

NCT ID:

NCT00087139

Start Date:

September 2004

Completion Date:

January 2014

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • metastatic prostate cancer
  • Prostatic Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
St. Rita's Medical CenterLima, Ohio  45801
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
CCOP - OchsnerNew Orleans, Louisiana  70121
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - ColumbusColumbus, Ohio  43206
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Southwest Medical CenterLiberal, Kansas  67901
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Bettendorf, Iowa  52722
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Terrebonne General Medical CenterHouma, Louisiana  70360
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Mercy Medical CenterSpringfield, Ohio  45504
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
St. Anthony Central HospitalDenver, Colorado  80204-1335
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Ochsner Health Center - BluebonnetBaton Rouge, Louisiana  70809
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Sherman HospitalElgin, Illinois  60120-2198
Central Pennsylvania Hematology and Medical Oncology Associates, PCLemoyne, Pennsylvania  17043
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Alexian Brothers Radiation OncologyElk Grove Village, Illinois  60007
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Hattiesburg Clinic, PA at Forrest GeneralHattiesburg, Mississippi  39401
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
Hematology & Oncology ClinicHattiesburg, Mississippi  39402
Langlade Memorial HospitalAntigo, Wisconsin  54409
UW Health UrologyMadison, Wisconsin  53715