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

Condition Treatment or Intervention Phase
stage IV breast cancer
recurrent 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 Stage IV Breast Cancer

Further Study Details: 

Study start: November 1994

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.

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 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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--


Location Information


Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States

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

Tennessee
      Methodist Hospital-Central Unit, Memphis,  Tennessee,  38104,  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:  CDR0000064017; SLUMC-7915; NCI-V95-0608
Record last reviewed:  August 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002628
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22
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