Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/10/2018 |
Start Date: | February 2009 |
Phase II Safety Study of Docetaxel and Carboplatin in Combination With Trastuzumab and Lapatinib in Early Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together
with carboplatin, trastuzumab, and lapatinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with
carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together
with carboplatin, trastuzumab, and lapatinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with
carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.
OBJECTIVES:
Primary
- Determine the safety and tolerability (including the rate of diarrhea) of adjuvant
therapy comprising docetaxel, carboplatin, trastuzumab (Herceptin®), and lapatinib
ditosylate in patients with early-stage breast cancer.
Secondary
- Evaluate the adverse event profile of this regimen in these patients.
- Evaluate LVEF in patients receiving this regimen.
OUTLINE: Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on
day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral
lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6
courses in the absence of disease progression or unacceptable toxicity. Patients then receive
trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days
1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the
absence of disease progression or unacceptable toxicity..
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for up to 8 years.
Primary
- Determine the safety and tolerability (including the rate of diarrhea) of adjuvant
therapy comprising docetaxel, carboplatin, trastuzumab (Herceptin®), and lapatinib
ditosylate in patients with early-stage breast cancer.
Secondary
- Evaluate the adverse event profile of this regimen in these patients.
- Evaluate LVEF in patients receiving this regimen.
OUTLINE: Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on
day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral
lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6
courses in the absence of disease progression or unacceptable toxicity. Patients then receive
trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days
1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the
absence of disease progression or unacceptable toxicity..
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for up to 8 years.
DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the
following criteria:
- Nonmetastatic disease
- Operable and adequately excised
- Patients with nonresectable deep margin invasion are eligible provided they
have had or will receive radiotherapy to the region
- Patients with histologically documented infiltration of the skin (pT4) are
eligible provided they have undergone or will receive radiotherapy
encompassing the tumor bed
- Node-positive OR -negative and determined eligible to receive adjuvant
trastuzumab (Herceptin®)
- No positive or suspicious internal mammary nodes by SNS that have not been or will not
be irradiated
- No supraclavicular lymph node involvement (confirmed by fine needle aspiration or
biopsy)
- Over expression and/or amplification of HER2 in the invasive component of the primary
tumor, according to one of the following:
- 3+ over-expression by IHC (> 30% of invasive tumor cells)
- 2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ
hybridization (FISH/CISH) test demonstrating HER2 gene amplification
- HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus, or a FISH
ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.)
- Negative or equivocal overall result (FISH test ratio of < 2.2, < 6.0
HER2-gene copies per nucleus) and staining scores of 0, 1+, 2+, or 3+ (in
30% or less neoplastic cells) by IHC not allowed
- Hormone receptor status known (estrogen receptor with or without progesterone
receptor)
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- Hemoglobin ≥ 10.0 g/dL
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if known Gilbert syndrome)
- Baseline LVEF ≥ 50% measured by ECHO or MUGA scan
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious cardiac illness or medical condition including, but not limited to, any of
the following:
- History of documented congestive heart failure (any NYHA class) or systolic
dysfunction (LVEF < 50%)
- High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade
atrioventricular-block [second degree or higher], or supraventricular arrhythmias
that are not adequately rate-controlled)
- Angina pectoris requiring antianginal medication
- Clinically significant valvular heart disease
- Evidence of transmural infarction on ECG
- Poorly controlled hypertension (any reading of systolic BP > 180 mm Hg or
diastolic BP > 100 mm Hg)
- No other concurrent serious diseases that may interfere with planned treatment
including severe pulmonary conditions or illness
- None of the following:
- Ulcerative colitis
- Malabsorption syndrome
- Any disease significantly affecting gastrointestinal function
- Inability to swallow oral medication
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior mediastinal irradiation except internal mammary-node irradiation for the
present breast cancer
- No prior anti-HER2 therapy for any reason
- No prior biologic or immunotherapy for breast cancer
- No prior resection of the stomach or small bowel
- No other concurrent anticancer therapy including chemotherapeutic agents, biologic
agents, or radiotherapy
- No concurrent anticancer treatment in another investigational trial with hormone
therapy or immunotherapy unless approved by the study chair
- No concurrent CYP3A4 inhibitors or inducers
- No concurrent epoetin alfa, including darbepoetin alfa
- No concurrent oprelvekin
We found this trial at
136
sites
Northwest Ohio Oncology Center The Northwest Ohio Oncology Center, located on the campus of ProMedica...
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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...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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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...
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Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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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...
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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...
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1101 N 27th St # 201
Billings, Montana 59101
Billings, Montana 59101
(406) 237-3585
St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
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Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
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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...
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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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...
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Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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St. James Healthcare Cancer Care The St. James Cancer Center is an integrated cancer treatment...
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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...
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Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
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Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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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...
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Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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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...
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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...
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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...
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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,...
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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...
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Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
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Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
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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...
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Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
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Northern Montana Hospital Northern Montana Hospital (NMH) is the center of a comprehensive system of...
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St. Peter's Hospital Welcome to St. Peter’s Hospital, providing premier health care to a five–county...
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Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
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Glacier Oncology, PLLC Glacier Oncology are physician clinics focusing exclusively on the medical subspecialties of...
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Kalispell Medical Oncology at KRMC Our commitment to integrating modern treatment programs with highly-trained physicians...
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Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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1007 LINCOLNWAY
La Porte, Indiana 46350
La Porte, Indiana 46350
219.326.1234
Center for Cancer Therapy at LaPorte Hospital and Health Services United in our mission, the...
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Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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Lima Memorial Hospital We also offer an extended network of primary care, pediatric and specialist...
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800 E 28th St
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
612-863-4000
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
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Montana Cancer Center at St. Patrick Hospital and Health Sciences Center St. Patrick Hospital is...
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500 John Deere Road
Moline, Illinois 61265
Moline, Illinois 61265
(309) 779-5000
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Located at 500 John...
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Community Cancer Center of Monroe The Monroe Cancer Center, a joint venture between the Barbara...
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Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Immanuel Medical Center Welcome to Alegent Creighton Immanuel Medical Center. Our campus, located in North...
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7500 Mercy Rd
Omaha, Nebraska 68124
Omaha, Nebraska 68124
(402) 398-6060
Alegent Health Cancer Center at Bergan Mercy Medical Center Welcome to Alegent Creighton Health Bergan...
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Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Reid Hospital & Health Care Services As you will see on campus and throughout our...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Park Nicollet Cancer Center Park Nicollet Methodist Hospital has a long and rich history in...
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United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
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Cancer Center of Kansas, PA - Salina Dr. H.E. Hynes founded Cancer Center of Kansas,...
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