Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer


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

Thank you

Trial Information

Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer


OBJECTIVES:

Primary

- Determine the pathological complete response rate in patients with stage II or III
breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim.

Secondary

- Determine the toxicity profile of this regimen in these patients.

- Determine the rate of breast-conserving surgery in patients treated with this regimen.

- Determine the clinical response rate in patients treated with this regimen.

- Determine the feasibility of drug administration, in terms of the percent of planned
dose actually administered per course, in patients treated with this regimen.

- Determine the proportion of patients with negative pathologic lymph node status after
treatment with this regimen.

- Determine the proportion of patients with residual ductal carcinoma in situ after
treatment with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1.
Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.

No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.

After completion of study therapy, patients are followed every 6 months until disease
progression and then annually for up to 5 years. Patients who do not complete all 4 courses
of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 21-23
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of breast cancer

- Clinical stage II or III disease (including T2-4, N0-3)

- No clinical or radiological evidence of distant metastases

- Isolated supraclavicular lymph node involvement allowed

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Male or female

Menopausal status

- Not specified

Performance status

- ECOG 0-1

Life expectancy

- At least 3 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL

Hepatic

- Bilirubin normal

- Meets 1 of the following criteria:

- AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal

- AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

- AST or ALT normal AND alkaline phosphatase ≤ 5 times ULN

Renal

- Creatinine clearance ≥ 30 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study
treatment

- No active unresolved infection

- No history of severe hypersensitivity reaction to docetaxel, carboplatin, or any
other drug formulated with polysorbate 80

- No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or
pegfilgrastim

- No peripheral neuropathy ≥ grade 2

- No other invasive malignancy within the past 5 years except curatively treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- No prior surgical resection for invasive breast cancer

Other

- No other prior therapy for invasive breast cancer

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate by histologic evaluation at definitive surgery

Safety Issue:

No

Principal Investigator

Vivek Roy, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000420834

NCT ID:

NCT00107510

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
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
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
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
Foote Hospital Jackson, Michigan  49201
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
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
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
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
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
Methodist Medical Center of Illinois Peoria, Illinois  61636
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Hinsdale, Illinois  60521
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
John Stoddard Cancer Center Des Moines, Iowa  50309
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Southwest Medical Center Liberal, Kansas  67901
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
Trinity Medical Center - East Moline, Illinois  61265
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. Margaret's Hospital Spring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Bettendorf, Iowa  52722
Mercy Capitol Hospital Des Moines, Iowa  50307
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
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Alexandria, Minnesota  56308
MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Bismarck Cancer Center Bismarck, North Dakota  58501
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
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Franciscan Skemp Healthcare - La Crosse Campus La Crosse, Wisconsin  54601
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502