Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer - Full Text View

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00007904

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.

Condition	Intervention	Phase
Breast Cancer	Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuos Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Than or Equal to 10 Lymph Nodes

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Tamoxifen Doxorubicin Doxorubicin hydrochloride Paclitaxel Tamoxifen citrate Myocet Filgrastim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival at 1 and 2 years [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	July 2000

Detailed Description:

OBJECTIVES:

Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving > 4 lymph nodes.
Determine the incidence of febrile neutropenia in these patients during the first course of therapy.
Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194.
Determine the disease-free and overall survival of patients treated with this regimen.
Evaluate the quality of life of these patients.
Correlate HER-2/neu overexpression with disease-free and overall survival in these patients.

OUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.

Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy.

Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage II or IIIA breast cancer
- At least 5 axillary lymph nodes
- No T4 or N3 disease
No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation
No more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection
- Negative surgical margins
Hormone receptor status:
- Hormone receptor status known

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Male or female

Menopausal status:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,500/mm^3
Granulocyte count at least 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 1.5 times ULN
Alkaline phosphatase no greater than 1.5 times ULN

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

No poorly controlled ischemic heart disease or congestive heart failure

Pulmonary:

No severe chronic obstructive or restrictive pulmonary disease

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No severe diabetes mellitus
No other severe concurrent medical or psychiatric illness that would preclude study participation
No other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007904

Locations

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Brenda W. Cooper, MD

Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068341, CASE-CWRU-1100, CWRU-050023, NCI-G00-1877, CASE-1100
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00007904 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage IIIA breast cancer
male breast cancer

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Breast Diseases

Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Mitosis Modulators
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Tamoxifen
Immunosuppressive Agents
Pharmacologic Actions
Doxorubicin
Neoplasms
Paclitaxel
Tubulin Modulators
Myeloablative Agonists

ClinicalTrials.gov processed this record on November 27, 2009