Clinical trial NCT00007904: Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes
Official title: A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage II breast cancer
stage IIIA breast cancer
male breast cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

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 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

Primary outcomes:
measure: To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide
timeFrame: 9 weeks
measure: To determine the incidence of febrile neutropenia with the first cycle of therapy.
timeFrame: 3 weeks
Secondary outcomes:
measure: To determine days of neutrophil counts below 500/uL on this regimen during the first treatment cycle.
timeFrame: after 1st cycle (3 weeks)
measure: To evaluate dose delays and dose reductions of this regimen.
timeFrame: at 7 cycles (21 weeks)
measure: To determine disease-free and overall survival of this regimen.
timeFrame: 5 yrs after treatment
measure: Quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire
timeFrame: 6 months after treatment
measure: Correlation of Her2/neu overexpression with disease-free and overall survival
timeFrame: 5 yrs after treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Mentor
country: United States
facility: UH-LUICC
state: Ohio
city: Orange Village
country: United States
facility: UH-Chagrin Highlands
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Brenda W. Cooper, MD
role: STUDY_CHAIR
References: