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

This study is no longer recruiting patients.

Sponsored by: St. Louis University
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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 when added to high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating women with breast cancer at high risk of relapse.

Condition Treatment or Intervention Phase
stage IIIB breast cancer
stage IIIA breast cancer
inflammatory breast cancer
stage II breast cancer
 Drug: carboplatin
 Drug: cyclophosphamide
 Drug: filgrastim
 Drug: mesna
 Drug: paclitaxel
Phase I
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Paclitaxel Added to High-Dose Carboplatin/Cyclophosphamide with Autologous Peripheral Blood Stem Cell Support for Women with High-Risk Stage II/III Breast Cancer

Further Study Details: 

Study start: November 1994

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--


Location Information


Missouri
      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States

Study chairs or principal investigators

Paul J. Petruska,  Study Chair,  St. Louis University   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064016; SLUMC-8038; NCI-V95-0607
Record last reviewed:  July 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002627
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22
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