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Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00007904   Information provided by National Cancer Institute (NCI)
First Received: January 6, 2001   Last Updated: February 6, 2009   History of Changes

January 6, 2001
February 6, 2009
July 2000
 
Disease-free survival at 1 and 2 years [ Designated as safety issue: No ]
Disease-free survival at 1 and 2 years
Complete list of historical versions of study NCT00007904 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer
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

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.

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.

Phase II
Interventional
Treatment
Breast Cancer
  • Biological: filgrastim
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: paclitaxel
  • Drug: tamoxifen citrate
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
26
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00007904
 
CDR0000068341, CASE-CWRU-1100, CWRU-050023, NCI-G00-1877, CASE-1100
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Brenda W. Cooper, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP