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Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carboplatin
cyclophosphamide
mesna
paclitaxel
peripheral blood stem cell transplantation
Sponsored by
St. Louis University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Cancer Center
  • St. Louis University Health Sciences Center
  • Methodist Hospital-Central Unit

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 9, 2014
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT00002628
Brief Title
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2000
Overall Recruitment Status
Unknown status
Study Start Date
November 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St. Louis University

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used. PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel added to a regimen of high-dose chemotherapy with cyclophosphamide and carboplatin followed by peripheral stem cell transplantation in treating women with metastatic breast cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
mesna
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J. Petruska, MD
Organizational Affiliation
St. Louis University
Official's Role
Study Chair
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5265
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Methodist Hospital-Central Unit
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

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Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer

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