Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CASE-CWRU-1100 CWRU-050023, NCI-G00-1877, NCT00007904, CASE-1100, CWRU1100

Objectives

1. 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.
2. Determine the incidence of febrile neutropenia in these patients during the first course of therapy.
3. 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.
4. Determine the disease-free and overall survival of patients treated with this regimen.
5. Evaluate the quality of life of these patients.
6. Correlate HER-2/neu overexpression with disease-free and overall survival in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

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/mm³
• Granulocyte count at least 1,500/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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

Outcomes

Disease-free survival at 1 and 2 years

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.

Trial Contact Information

Trial Lead Organizations

Case Comprehensive Cancer Center

Brenda Cooper, MD, Protocol chair		Ph: 216-844-3213 Email: bxc12@po.cwru.edu

Registry Information
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
Trial Start Date		2000-07-18
Registered in ClinicalTrials.gov		NCT00007904
Date Submitted to PDQ		2000-10-17
Information Last Verified		2006-12-03
NCI Grant/Contract Number		CA43703

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