Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/10/2018 |
Start Date: | June 2010 |
End Date: | November 1, 2014 |
Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer
This phase II trial studies how well brostallicin and cisplatin work in treating patients
with breast cancer that has spread to other parts of the body (metastatic) and does not have
estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor
receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as
brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from spreading.
with breast cancer that has spread to other parts of the body (metastatic) and does not have
estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor
receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as
brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from spreading.
PRIMARY OBJECTIVES:
I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast
cancer patients having a triple negative (estrogen receptor [ER]/progesterone receptor
[PR]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months.
SECONDARY OBJECTIVES:
I. To describe the confirmed tumor response rate of patients with measurable disease
receiving brostallicin and cisplatin.
II. To describe the duration of response in patients with measurable disease receiving
brostallicin and cisplatin.
III. To describe the 6-month progression-free survival of patients receiving brostallicin and
cisplatin.
IV. To describe the overall survival (OS) of patients receiving brostallicin and cisplatin.
V. To evaluate the adverse event profile of the study regimen (adverse events graded using
the Cancer Therapy Evaluation Program [CTEP] Active Version of the Common Terminology
Criteria for Adverse Events [CTCAE]).
OUTLINE:
Patients receive cisplatin intravenously (IV) over 2 hours on day 1 and brostallicin IV over
10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until disease
progression and then every 6 months for up to 5 years.
I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast
cancer patients having a triple negative (estrogen receptor [ER]/progesterone receptor
[PR]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months.
SECONDARY OBJECTIVES:
I. To describe the confirmed tumor response rate of patients with measurable disease
receiving brostallicin and cisplatin.
II. To describe the duration of response in patients with measurable disease receiving
brostallicin and cisplatin.
III. To describe the 6-month progression-free survival of patients receiving brostallicin and
cisplatin.
IV. To describe the overall survival (OS) of patients receiving brostallicin and cisplatin.
V. To evaluate the adverse event profile of the study regimen (adverse events graded using
the Cancer Therapy Evaluation Program [CTEP] Active Version of the Common Terminology
Criteria for Adverse Events [CTCAE]).
OUTLINE:
Patients receive cisplatin intravenously (IV) over 2 hours on day 1 and brostallicin IV over
10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until disease
progression and then every 6 months for up to 5 years.
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast with clinical
evidence of metastatic disease
- Triple negative breast cancer defined as HER2-(according to current American Society
of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines), ER-
(defined as =< 1% by IHC) and PgR- (defined as =< 1% by IHC)
- 0 to 4 prior chemotherapy regimens in the metastatic setting
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
criteria
- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only
- Hemoglobin >= 10.0 g/dL
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelet count >= 100,000/mL
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Serum creatinine =< 1.5 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x
ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases
- Alkaline phosphatase =< 2.5 x ULN or alkaline phosphatase =< 5 x ULN if elevations are
due to liver metastases
- Electrocardiogram (EKG) completed =< 15 days prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- Life expectancy > 3 months
- Has written informed consent
- Willingness to return to NCCTG enrolling institution for treatment and follow-up
- Patient willing to provide blood samples for research purposes
Exclusion Criteria
- HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified)
breast cancer by ASCO/CAP guidelines
- Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer
(defined as > 1% of either receptor by IHC)
- Any of the following
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate
contraception (as determined by the treating physician) while on this study and
for 30 days after end of treatment with the study drugs
- Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration
- Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the
CTCAE)
- Major surgery =< 4 weeks prior to registration
- Chemotherapy or immunologic therapy =< 3 weeks prior to registration
- Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only
* NOTES:
- Prior radiation to a target lesion is permitted only if there has been clear
progression of the lesion since radiation was completed
- If patient receives single dose radiation for palliation or radiation to
non-target lesion, they may immediately proceed to registration without waiting 2
weeks
- Acute adverse events from radiation must have resolved to =< grade 1 (according
to the CTEP active version of the CTCAE)
- Evidence of active brain metastasis including leptomeningeal involvement
* NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or
radiotherapy is allowed; to be considered controlled, there must be at least 2 months
of no symptoms or evidence of progression prior to study entry and corticosteroid
therapy given to control brain edema must have been discontinued
- History of allergy or hypersensitivity to the drugs used in this study (or their
excipients) including platinum compounds (cisplatin, carboplatin)
- Active, unresolved infection
- Uncontrolled intercurrent illness including, but not limited to psychiatric
illness/social situations or co-morbid systemic illnesses or other severe concurrent
disease which, in the judgment of the investigator, would make the patient
inappropriate for entry into this study or would interfere significantly with the
proper assessment of safety of the prescribed regimens or would limit compliance with
study requirements or would make it undesirable for patient to participate in the
trial
- Clinically significant cardiovascular or cerebrovascular disease, including any
history of the following =< 6 months prior to registration:
- Myocardial infarction
- Unstable angina
- New York Heart Association (NYHA) class II or greater congestive heart failure
- Uncontrolled or clinically significant cardiac arrhythmia (patients with
controlled atrial fibrillation are eligible)
- Currently receiving treatment in a different clinical study in which investigational
procedures are performed or investigational therapies are administered
* NOTE: Patient may not enroll in such clinical trials while participating in this
study; exception may be granted for trials related to symptom management (cancer
control) which do not employ hormonal treatments or treatments that may block the path
of the targeted agents used in this trial
- Immunocompromised patients (other than that related to the use of corticosteroids)
including patients known to be human immunodeficiency virus (HIV) positive with an
acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients
with cluster of differentiation (CD)4 count within institutional normal range and no
history of an AIDS-defining illness are eligible
We found this trial at
266
sites
Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
Click here to add this to my saved trials
3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
Click here to add this to my saved trials
1719 East 19th Avenue
Denver, Colorado 80218
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
Click here to add this to my saved trials
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
Click here to add this to my saved trials
19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
Click here to add this to my saved trials
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
Click here to add this to my saved trials
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
Click here to add this to my saved trials
Click here to add this to my saved trials
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
Click here to add this to my saved trials
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
Click here to add this to my saved trials
5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
Click here to add this to my saved trials
Aurora Presbyterian Hospital At The Medical Center of Aurora and Centennial Medical Plaza, we treat...
Click here to add this to my saved trials
Click here to add this to my saved trials
300 North Ave
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
Click here to add this to my saved trials
8111 South Emerson Avenue
Beech Grove, Indiana 46237
Beech Grove, Indiana 46237
(317) 528-5000
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2900 12th Ave N Ste 160W
Billings, Montana 59101
Billings, Montana 59101
(406) 238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
Click here to add this to my saved trials
Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
Click here to add this to my saved trials
720 E Rosser Ave
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
Click here to add this to my saved trials
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
Click here to add this to my saved trials
900 East Broadway
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
701.530.7000
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
Click here to add this to my saved trials
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
Click here to add this to my saved trials
St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
Click here to add this to my saved trials
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
Click here to add this to my saved trials
Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
Click here to add this to my saved trials
Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
Click here to add this to my saved trials
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
Click here to add this to my saved trials
St. James Healthcare Cancer Care The St. James Cancer Center is an integrated cancer treatment...
Click here to add this to my saved trials
Graham Hospital At Graham Hospital, we have a proud and rich history of serving the...
Click here to add this to my saved trials
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
Click here to add this to my saved trials
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
Click here to add this to my saved trials
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
Click here to add this to my saved trials
701 10th St SE
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
(319) 365-4673
Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
Click here to add this to my saved trials
Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
Click here to add this to my saved trials
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
Click here to add this to my saved trials
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
Click here to add this to my saved trials
Click here to add this to my saved trials
Mercy Cancer Center - West Lakes When it comes to cancer care, there
Click here to add this to my saved trials
2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
(719) 776-5000
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
Click here to add this to my saved trials
Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
Click here to add this to my saved trials
11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
Click here to add this to my saved trials
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
Click here to add this to my saved trials
18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
Click here to add this to my saved trials
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
Click here to add this to my saved trials
St. Anthony Central Hospital The St. Anthony Medical Campus in Lakewood combines our heritage of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
Click here to add this to my saved trials
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
Click here to add this to my saved trials
Click here to add this to my saved trials
300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
Click here to add this to my saved trials
1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
Click here to add this to my saved trials
1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
Click here to add this to my saved trials
411 Laurel St New Visions
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3970
Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
Click here to add this to my saved trials
411 Laurel Street
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
Click here to add this to my saved trials
Click here to add this to my saved trials
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
Click here to add this to my saved trials
Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
Click here to add this to my saved trials
Community Cancer Center When you have cancer, you might think first of treatments
Click here to add this to my saved trials
Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
Click here to add this to my saved trials
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
Click here to add this to my saved trials
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
Click here to add this to my saved trials
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
Click here to add this to my saved trials
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
Click here to add this to my saved trials
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
Click here to add this to my saved trials
Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
550 Osborne Road
Fridley, Minnesota 55432
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
Click here to add this to my saved trials
Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
Click here to add this to my saved trials
Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
Click here to add this to my saved trials
960 S. Columbia Rd.
Grand Forks, North Dakota 58201
Grand Forks, North Dakota 58201
701-780-5400
Altru Cancer Center at Altru Hospital From chemotherapy and radiation therapy to personal holistic services,...
Click here to add this to my saved trials
2635 North 7th Street
Grand Junction, Colorado 81501
Grand Junction, Colorado 81501
970-298-CARE (2273)
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center St. Mary's Hospital...
Click here to add this to my saved trials
Click here to add this to my saved trials
250 Cherry St SE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 685-5225
Lacks Cancer Center at Saint Mary's Health Care Mercy Health Lacks Cancer Center was one...
Click here to add this to my saved trials