PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO THE HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH BREAST CANCER
18 Years
65 Years
Female
Breast Cancer
Trial Information
PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO THE HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH BREAST CANCER
OBJECTIVES: I. Estimate the maximum tolerated dose of paclitaxel in combination with
high-dose carboplatin/cyclophosphamide followed by autologous peripheral blood stem cell
support in women with stage IV breast cancer. II. Assess the nonhematologic toxic effects
associated with this combination. III. Assess the response rate, duration of response, and
survival in chemotherapy-sensitive women with metastatic breast cancer treated with this
regimen.
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 24-hour infusion, followed by fixed doses of high-dose cyclophosphamide for 2 days,
then carboplatin for 4 days. Three 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, and every 4-6 months
thereafter.
PROJECTED ACCRUAL: 50 patients will be accrued. The study is expected to take 18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically diagnosed, stage IV adenocarcinoma of the breast
Previously untreated or prior adjuvant chemotherapy only CR or PR following 3-5 courses of
induction chemotherapy for current diagnosis with one of the following:
Cyclophosphamide/doxorubicin Cyclophosphamide/methotrexate/fluorouracil
Cyclophosphamide/mitoxantrone No active CNS metastases on CT or MRI Hormone receptor
status: Any status
PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women Menopausal status: Pre- or
postmenopausal Performance status: ECOG 0-2 Hematopoietic: WBC greater than 3,000
Platelets greater than 100,000 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal:
Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection
fraction greater than 50% on MUGA or echocardiogram No abnormal cardiac conduction on EKG,
i.e.: No second- or third-degree heart block No bundle-branch block No arrhythmia except:
Supraventricular sinus tachycardia Occasional premature atrial or ventricular contractions
Pulmonary: DLCO greater than 60% of predicted Other: No preexisting peripheral neuropathy
No HIV antibody No history of second malignancy within 5 years except: Nonmelanomatous
skin cancer Cervical carcinoma in situ No pregnant or nursing women
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Hematologically
recovered from prior chemotherapy Endocrine therapy: Failure on 1 prior hormonal regimen
required for ER-positive disease (greater than 10 femtomoles) unless visceral metastatic
crisis requires immediate chemotherapy Radiotherapy: Not specified Surgery: Not specified
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:
CDR0000064017
NCT ID:
NCT00002628
Start Date:
November 1994
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| Methodist Hospital-Central Unit | Memphis, Tennessee 38104 |
