Breast Cancer Clinical Trial

Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

Summary

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. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer.

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility 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

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:

Surgery

No prior surgical resection for invasive breast cancer

Other

No other prior therapy for invasive breast cancer

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00107510

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 97 Locations for this study

See Locations Near You

Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
St. Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
Trinity Medical Center - East
Moline Illinois, 61265, United States

Moline Illinois, 61265, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Reid Hospital & Health Care Services, Incorporated
Richmond Indiana, 47374, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States

Bettendorf Iowa, 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center
Des Moines Iowa, 50316, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48909, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
MeritCare Clinic - Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States

Fergus Falls Minnesota, 56537, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Coborn Cancer Center
Saint Cloud Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CentraCare Clinic - River Campus
St. Cloud Minnesota, 56303, United States
Park Nicollet Health Services
St. Louis Park Minnesota, 55416, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck North Dakota, 58502, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Broadway
Fargo North Dakota, 58122, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Geisinger Medical Group - Scenery Park
State College Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse Wisconsin, 54601, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00107510

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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