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Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer


OBJECTIVES:

Primary

- To assess the proportion of confirmed tumor responses in patients with HER2-negative
metastatic breast cancer treated with pixantrone dimaleate.

Secondary

- To describe the distribution of progression-free survival (PFS) times of patients
treated with this drug.

- To assess the 6-month PFS rate in patients treated with this drug.

- To describe the overall survival of patients treated with this drug.

- To assess the adverse event profile of this drug in these patients.

- To evaluate the quality of life and patient-reported symptoms of patients treated with
this drug.

- To evaluate quantitative and qualitative changes of circulating tumor cells after
pixantrone dimaleate therapy. (Correlative study)

- To bank blood and tissue samples for future evaluation of pharmacogenetic and/or
proteomic markers. (Correlative study)

OUTLINE: This is a multicenter study. Patients are randomized according to prior doxorubicin
treatment ( yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats
every 21 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15.
Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

Some patients undergo blood sample collection at baseline and periodically during study for
circulating tumor cells analysis by CellSearch System and mRNA isolation assays.

Patients complete quality-of-life questionnaires using the Linear Analogue Self Assessment
(LASA6) and the Patient-Reported Outcomes Version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE) at baseline and periodically during study.

After completion of study therapy, patients are followed up every 3-6 months for up to 5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the breast

- Metastatic disease

- Must have been treated in neoadjuvant, adjuvant, or metastatic setting with
anthracycline and/or taxane

- Must have received 2-3 prior chemotherapy regimens

- Received ≤ 2 prior chemotherapy regimens in the metastatic setting if no prior
neoadjuvant or adjuvant chemotherapy

- Received ≥ 1 prior chemotherapy regimen in the metastatic setting if prior
neoadjuvant or adjuvant chemotherapy

- Measurable disease

- HER2-negative disease

- No active brain metastasis, including leptomeningeal involvement

- CNS metastasis controlled by prior surgery and/or radiotherapy allowed

- There must be ≥ 2 months of no symptoms or evidence of progression

- Patient must discontinue corticosteroid to control brain edema

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy > 3 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 5 times ULN

- Serum creatinine ≤ 1.5 times ULN

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- LVEF ≥ 50% and EKG normal within the past 22 days

- No other prior stage III or IV invasive cancer within the past 3 years except
curatively treated nonmelanoma skin cancer

- No uncontrolled hypertension (BP > 160/90 mm Hg on ≥ 2 occasions)

- Patients on any stable new regimen or adjusted anti-hypertensive medications
allowed provided BP < 140/90 mmHg for ≥ 3 different observations in ≥ 14 days

- No clinically significant cardiovascular or cerebrovascular disease, including any
history of the following:

- Myocardial infarction

- Unstable angina pectoris

- NYHA class II-IV congestive heart failure

- Uncontrolled or clinically significant cardiac arrhythmia

- Controlled atrial fibrillation allowed

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Psychiatric illness and/or social situations that would limit compliance with
study requirements

- No co-morbid systemic illnesses or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed drug

- No history of allergy or hypersensitivity to drug product excipients or agents
chemically similar to pixantrone dimaleate

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 3 prior chemotherapy regimens for breast cancer

- This number includes neoadjuvant or adjuvant chemotherapy, if given

- If neoadjuvant or adjuvant chemotherapy has been giving it counts as 1 regimen

- Unlimited prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting
allowed

- Lifetime cumulative treatment with doxorubicin ≤ 400 mg/m²

- More than 3 weeks since prior major surgery, chemotherapy, or immunologic therapy

- At least 4 weeks since prior bevacizumab

- No prior radiotherapy within the past 4 weeks and recovered

- Radiotherapy to non-target lesions allowed

- Prior radiotherapy to a target lesion allowed provided there has been clear
progression of the lesion since completion of radiotherapy

- Palliative single dose of radiotherapy allowed

- No other concurrent chemotherapy, biologic agents, or radiotherapy

- No concurrent investigational procedures or investigational therapies

- Trials related to symptom management that do not employ hormonal treatments or
treatments that may block the path of the targeted agents used in this trial may
be allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed tumor responses (complete or partial response)

Safety Issue:

No

Principal Investigator

Kostandinos Sideras, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000667253

NCT ID:

NCT01086605

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • HER2-negative breast cancer
  • male breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Hurley Medical Center Flint, Michigan  48503
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington, West Virginia  25701
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa Regional Ottumwa, Iowa  52501
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Front Range Cancer Specialists Fort Collins, Colorado  80528
Poudre Valley Hospital Fort Collins, Colorado  80524
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Community Cancer Center of Monroe Monroe, Michigan  48162
St. Joseph's Medical Center Brainerd, Minnesota  56401
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
Reid Hospital & Health Care Services Richmond, Indiana  47374
McFarland Clinic, PC Ames, Iowa  50010
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Michiana Hematology Oncology PC - Niles Niles, Michigan  49120
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Mary Rutan Hospital Bellefontaine, Ohio  43311
North Coast Cancer Care - Clyde Clyde, Ohio  43410
Grant Medical Center Cancer Care Columbus, Ohio  43215
Hematology Oncology Center Elyria, Ohio  44035
Community Cancer Center Elyria, Ohio  44035
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Fisher-Titus Medical Center Norwalk, Ohio  44857
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Guthrie Cancer Center at Guthrie Clinic Sayre Sayre, Pennsylvania  18840
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Rocky Mountain Oncology Casper, Wyoming  82609
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Maui Memorial Medical Center Wailuku, Hawaii  96793
Pacific Cancer Institute - Maui Wailuku, Hawaii  96793
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Galesburg Galesburg, Illinois  61401
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
AnMed Cancer Center Anderson, South Carolina  29621
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Lakeview Hospital Stillwater, Minnesota  55082
Kauai Medical Clinic Lihue, Hawaii  96766
Goldschmidt Cancer Center Jefferson City, Missouri  65109
Comprehensive Cancer Care, PC Saint Louis, Missouri  63141
University of New Mexico Cancer Center - South Las Cruces, New Mexico  88011
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
St. Nicholas Hospital Sheboygan, Wisconsin  53081
Mercy Cancer Center - West Lakes Clive, Iowa  50325
Methodist West Hospital West Des Moines, Iowa  50266-7700