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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00027885 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This randomized phase II trial is to see if docetaxel with or without bevacizumab followed by surgery, radiation therapy, and combination chemotherapy works better in treating patients who have stage III or stage IV breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: bevacizumab Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Bevacizumab in Combination With Docetaxel in Locally Advanced Breast Cancer |
| Enrollment: | 49 |
| Study Start Date: | November 2001 |
| Estimated Study Completion Date: | April 2015 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
|
Drug: cyclophosphamide
Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
Other Name: Taxotere
Drug: doxorubicin hydrochloride
Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Procedure: adjuvant therapy
After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks. Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.
Procedure: neoadjuvant therapy
Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8. Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
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|
Experimental: Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
|
Biological: bevacizumab
Patients receive bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
Drug: cyclophosphamide
Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: doxorubicin hydrochloride
Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Procedure: adjuvant therapy
After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks. Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.
Procedure: neoadjuvant therapy
Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8. Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
|
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to disease stage. Patients are randomized to 1 of 2 treatment arms.
After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with estrogen and/or progesterone receptor-positive disease also receive oral tamoxifen daily for 5 years beginning after the completion of chemotherapy. Post-menopausal patients may receive oral anastrozole once daily for 5 years instead of tamoxifen.
Patients are followed at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No arterial thromboembolic event within the past 6 months including the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent cytokines during docetaxel/bevacizumab administration
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5055 | |
| UH-Southwest | |
| Middleburgh Heights, Ohio, United States, 44130 | |
| UH-Chagrin Highlands | |
| Orange Village, Ohio, United States, 44122 | |
| UH-Green Road | |
| South Euclid, Ohio, United States, 44121 | |
| UH-Westlake | |
| Westlake, Ohio, United States, 44145 | |
| Study Chair: | Paula Silverman, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Paula Silverman, M.D., Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00027885 History of Changes |
| Other Study ID Numbers: | CWRU3100, U01CA062502, P30CA043703, CWRU-3100, NCI-2722 |
| Study First Received: | December 7, 2001 |
| Last Updated: | June 13, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
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stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Docetaxel Bevacizumab Doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |