|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00021086 |
Purpose
RATIONALE: Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy such as docetaxel and doxorubicin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel and doxorubicin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with docetaxel and doxorubicin in treating patients who have inflammatory or locally advanced stage IIB or stage III breast cancer that has not been previously treated with chemotherapy and/or radiation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: bevacizumab Biological: filgrastim Biological: pegfilgrastim Drug: docetaxel Drug: doxorubicin hydrochloride Procedure: conventional surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study To Evaluate Angiogenesis After Treatment With Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) In Previously Untreated Patients With Inflammatory Breast Cancer or Locally Advanced Breast Cancer |
| Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 of courses 1-7. Patients also receive doxorubicin IV and docetaxel IV over 1 hour on day 1 and filgrastim (G-CSF) subcutaneously (SC) on days 2-11 or pegfilgrastim SC on day 2 of courses 2-7. Treatment repeats every 3 weeks for 7 courses in the absence of disease progression or unacceptable toxicity.
After completion of course 7, patients undergo reassessment of need for surgery.
After completion of any surgery, patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who are estrogen receptor and/or progesterone receptor positive may receive oral tamoxifen or anastrozole daily for 5 years beginning with course 8 of bevacizumab.
Patients are followed every 3 months for 1 year and then every 3-6 months for 2 years.
PROJECTED ACCRUAL: A total of 23 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed inflammatory or locally advanced stage IIB, IIIA, IIIB, or IIIC breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No uncontrolled hypertension
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Suparna B. Wedam, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000068746, NCI-01-C-0173, NCI-2772 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00021086 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
stage IIIC breast cancer inflammatory breast cancer male breast cancer |
|
Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Bevacizumab Antibiotics, Antineoplastic Angiogenesis Inhibitors Doxorubicin |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Breast Diseases |