Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
This study has been completed.
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00107510
First received: April 5, 2005
Last updated: August 18, 2012
Last verified: July 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: pegfilgrastim Drug: carboplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Pathological complete response rate by histologic evaluation at definitive surgery [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity profile by CTCAE v3.0 at baseline and each subsequent evaluation [ Designated as safety issue: Yes ]
- Rate of breast conserving surgery at definitive surgery after neoadjuvant chemotherapy [ Designated as safety issue: No ]
- Clinical response rate by clinical examination prior to definitive surgery [ Designated as safety issue: No ]
| Estimated Enrollment: | 58 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107510
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| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Moline, Illinois, United States, 61265 | |
| Trinity Medical Center - East | |
| Moline, Illinois, United States, 61265 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | |
| Beech Grove, Indiana, United States, 46107 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| United States, Iowa | |
| McFarland Clinic, PC | |
| Ames, Iowa, United States, 50010 | |
| Bettendorf, Iowa, United States, 52722 | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50316-2301 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Saint Joseph Mercy Cancer Center | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48909 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| United States, Minnesota | |
| MeritCare Clinic - Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| St. Mary's - Duluth Clinic Cancer Center | |
| Duluth, Minnesota, United States, 55805 | |
| Miller - Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Minnesota Oncology Hematology, PA - Maplewood | |
| Maplewood, Minnesota, United States, 55109 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| United States, Nebraska | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510 | |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| Immanuel Medical Center | |
| Omaha, Nebraska, United States, 68122 | |
| United States, North Dakota | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| Medcenter One Hospital Cancer Care Center | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center Cancer Center | |
| Bismarck, North Dakota, United States, 58502 | |
| Mid Dakota Clinic, PC | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Broadway | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57701 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Wisconsin | |
| Franciscan Skemp Healthcare - La Crosse Campus | |
| La Crosse, Wisconsin, United States, 54601 | |
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Study Chair: | Vivek Roy, MD, FACP | Mayo Clinic |
| Investigator: | Edith A. Perez, MD | Mayo Clinic |
| Investigator: | Robert T. Chambers, MD, FRCSC, FACS | MeritCare Wahpeton |
| Investigator: | Judith E. Hurley, MD | University of Miami Sylvester Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
Apsey H, Roy V, Pockaj B, et al.: Surgical practice patterns following NCCTG N0338 "Phase II trial of docetaxel and darboplatin administered every two weeks as induction therapy for stage II and stage III breast cancer". [Abstract] J Clin Oncol 27 (Suppl 15): A-623, 2009.
Pockaj BA, Mukherjee P, Tinder TL, et al.: NCCTG N0338: effect of docetaxel and carboplatin on VEGF, PGE2, and immune cells in patients with stage II or III breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-5110, 2008.
Reinholz MM, Kitzmann KK, Hillman D, et al.: Differential gene expression in circulating tumor cells between primary and metastatic breast cancer patients. [Abstract] Breast Cancer Res Treat 106 (1): A-5022, S213-4, 2007.
| ClinicalTrials.gov Identifier: | NCT00107510 History of Changes |
| Other Study ID Numbers: | CDR0000420834, NCCTG-N0338 |
| Study First Received: | April 5, 2005 |
| Last Updated: | August 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013