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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004092 |
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.
PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: filgrastim Drug: paclitaxel Drug: thiotepa Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | May 1999 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (ACT) (closed to accrual as of 4/6/2006): Experimental
Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.
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Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: filgrastim
Given IV or subcutaneously
Drug: paclitaxel
Given IV
Procedure: peripheral blood stem cell transplantation
Patients receive autologous peripheral blood stem cells
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Arm II (STAMP V): Active Comparator
Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.
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Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: filgrastim
Given IV or subcutaneously
Drug: thiotepa
Given IV
Procedure: peripheral blood stem cell transplantation
Patients receive autologous peripheral blood stem cells
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OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified by stage of disease.
Peripheral blood stem cells (PBSC) are collected after mobilization with filgrastim (G-CSF), administered subcutaneously or IV, twice daily beginning 3 days before collection and continuing until collection is complete.
All patients receive conventional-dose adjuvant chemotherapy, probably comprising doxorubicin IV, cyclophosphamide IV, and fluorouracil IV over 1 hour on days 1, 22, 43, and 64. Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy. (Arm I closed to accrual as of 4/6/2006.)
Within 4-6 weeks of day 0 of high-dose chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years. Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years.
Quality of life is assessed before therapy, at 30 days after high-dose chemotherapy, and at 6 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | up to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Arizona | |
Banner Good Samaritan Medical Center | Recruiting |
Phoenix, Arizona, United States, 85006 | |
Contact: Jeffrey R. Schriber, MD 602-239-4526 jeffrey.schriber@bannerhealth.com | |
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org |
Responsible Party: | City of Hope Comprehensive Cancer Center ( George Somlo ) |
Study ID Numbers: | CDR0000067305, CHNMC-IRB-98096, CHNMC-PHII-18, NCI-H99-0038 |
Study First Received: | December 10, 1999 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00004092 |
Health Authority: | Unspecified |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Skin Diseases Paclitaxel Breast Neoplasms Carboplatin |
Cyclophosphamide Doxorubicin Breast Diseases Thiotepa |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |