Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00002627|
Recruitment Status : Unknown
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 29, 2004
Last Update Posted : January 10, 2014
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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: mesna Drug: paclitaxel Procedure: peripheral blood stem cell transplantation||Phase 1 Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH HIGH RISK STAGE II AND III BREAST CANCER|
|Study Start Date :||November 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002627
|United States, Missouri|
|St. Louis University Health Sciences Center|
|Saint Louis, Missouri, United States, 63110-0250|
|Study Chair:||Paul J. Petruska, MD||St. Louis University|