Methotrexate |
Rheumatrex; Trexall |
Clinical Trial: Bevacizumab with Or Without Cyclophosphamide and Methotrexate: a Pilot Study in Women with Operable Breast Cancer
This study is currently recruiting patients.
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Breast Cancer | Drug: Bevacizumab Drug: Cyclophosphamide Drug: Methotrexate | Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Anti-Angiogenesis Treatment After Preoperable Chemotherapy: a Pilot Study in Women with Operable Breast Cancer
Secondary Outcomes: Monitor changes in left ventricular ejection fraction (LVEF); rate of recurrence, either local or distant; look at blood markers to determine how treatment is working; explore predictors of tumor recurrence after preoperative chemotherapy and during bevacizumab-based adjuvant therapy; characterize safety of radiation therapy immediately followed by bevacizumab or bevacizumab plus metronomic chemotherapy
Expected Total Enrollment: 100
Study start: June 2005
- This study is broken into 2 groups (A and B) and is currently enrolling for Group A only. Group A will consist of 60 patients and once it is full, Group B will start enrolling. Group B will consist of 40 patients.
- Patients in Group A are treated with bevacizumab every 3 weeks for 12 months. Prior to each bevacizumab administration, a physical exam, blood tests and urine test will be performed.
- Patients in Group B are treated with bevacizumab (once every 3 weeks), cyclophosphamide (once daily), and methotrexate (twice daily for the first 2 days of each week) for 6 months. Then for the subsequent 6 months, with bevacizumab (once every 3 weeks) only. Prior to bevacizumab administration, a physical exam, blood tests and urine test will be performed.
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
- Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.
- Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.
- For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.
- Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.
- LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.
- ECOG performance status 0-1
Exclusion Criteria:
- Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment
- Patients with metastatic disease are ineligible.
- Known HIV infection
- Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding
- Uncontrolled intercurrent illness
- Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment
- History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab
- Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded
- History of bleeding diathesis or coagulopathy
- History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)
- Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer
- Patients with large or rapidly accumulating pleural or abdominal effusions
- Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR
- Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed
- Patients may not receive other investigational agents while on study
Location and Contact Information
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Harold Burstein, MD, PhD, Principal Investigator
Eric Winer, MD, Sub-Investigator
Craig Bunnell, MD, Sub-Investigator
Wendy Chen, MD, Sub-Investigator
Susana Campos, MD, Sub-Investigator
Ursula Matulonis, MD, Sub-Investigator
Judy Garber, MD, Sub-Investigator
Lyndsay Harris, MD, Sub-Investigator
Lawrence N Shulman, MD, Sub-Investigator
Jennifer Ligibel, MD, Sub-Investigator
Ian Krop, MD, PhD, Sub-Investigator
Ann Partridge, MD, Sub-Investigator
Daniel Silver, MD, Sub-Investigator
Karen Anderson, MD, PhD, Sub-Investigator
Leroy Parker, MD, Sub-Investigator
Rochelle Scheib, MD, Sub-Investigator
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115, United States; Recruiting
Steven E. Come, MD, Principal Investigator
Gerberg Wulf, MD, Sub-Investigator
Nadine Tung, MD, Sub-Investigator
Susan Schumer, MD, Sub-Investigator
Roger Lange, MD, Sub-Investigator
Lowell Schnipper, MD, Sub-Investigator
Harold J Burstein, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
More Information
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 20, 2005
ClinicalTrials.gov Identifier: NCT00121134
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- Methotrexate (Drug Digest)
- Methotrexate (Cleveland Clinic)

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