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PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH HIGH RISK STAGE II AND III BREAST CANCER


Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH HIGH RISK STAGE II AND III BREAST CANCER


OBJECTIVES: I. Estimate the maximum tolerated dose of paclitaxel when given with high-dose
carboplatin/cyclophosphamide with autologous peripheral blood stem cell support in women
with high-risk stage II/III breast cancer. II. Assess the nonhematologic toxicities
associated with this combination. III. Assess the progression-free and overall survival of
these patients following this treatment.

OUTLINE: This is a dose-finding study. All patients undergo collection of peripheral blood
stem cells (PBSC) with granulocyte colony-stimulating factor (G-CSF) mobilization prior to
high-dose chemotherapy. Cohorts of 3-5 patients are treated at successively higher dose
levels of paclitaxel until a maximum tolerated dose (MTD) is found. Paclitaxel is given as a
single 6-hour infusion, followed by fixed doses of high-dose cyclophosphamide for 2 days,
then carboplatin for 3 days. Four days later, patients receive PBSC and G-CSF for
hematopoietic reconstitution. Additional patients are entered at the MTD. Patients are
followed every 3 months for 1 year, every 4 months for 1 year, then every 4-6 months
thereafter.

PROJECTED ACCRUAL: It is expected that 24-30 patients will be accrued; a study duration of
1-1.5 years is anticipated.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically diagnosed adenocarcinoma of the breast of the
following stages: Stage II/IIIA disease with 4 or more involved axillary lymph nodes Stage
IIIB Inflammatory No bone marrow involvement documented on bone marrow aspiration and
biopsy Prior breast cancer allowed Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women only Menopausal status: Not specified
Performance status: Karnofsky 70%-100% Hematopoietic: Not specified Hepatic: Bilirubin no
greater than 2.0 mg/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left
ventricular ejection fraction at least 50% by MUGA No abnormal cardiac conduction
documented as second- or third-degree heart block or bundle branch block Pulmonary: DLCO
at least 60% of predicted Other: Not HIV positive No history of second malignancy within 5
years except: Nonmelanomatous skin cancer In situ carcinoma of the cervix No pregnant
women

PRIOR CONCURRENT THERAPY: At least 3 courses of induction therapy required, with regimen
at the discretion of the investigator No disease progression during induction

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul J. Petruska, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Louis University

Authority:

United States: Federal Government

Study ID:

CDR0000064016

NCT ID:

NCT00002627

Start Date:

November 1994

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • inflammatory breast cancer
  • Breast Neoplasms

Name

Location

St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250