Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 to 65 Other SLUMC-8038 NCI-V95-0607

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.

Entry 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

Prior/Concurrent Therapy:

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

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

Projected Accrual

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

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

St. Louis University Hospital Cancer Center

Paul Petruska, MD, Protocol chair		Ph: 314-268-5451 Email: petruspj@slu.edu

Back to Top