Status:
TERMINATED
Phase I Study of Aprotinin in Advanced Breast Cancer
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
PHASE1
Brief Summary
There is an intimate relationship between processes which promote growth, invasion, and metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and PAI-1 are key regulators...
Detailed Description
Urokinase-type plasminogen activator (uPA) is a serine protease whose physiologic function is to catalyze the conversion of plasminogen to the active proteolytic form, plasmin, for participation in pr...
Eligibility Criteria
Inclusion
- Patients with a histologically or cytologically proven metastatic breast cancer.
- Patients with at least one bidimensionally measurable lesion (diameter \> 1 cm), or an evaluable bone lesion that will not undergo biopsy.
- Age \> 18 years.
- Life expectancy of at least 6 months.
- ECOG performance status 0-3.
- Screening laboratories within the following parameters: ANC \> 1500 cells/mm3, Platelets \> 100,000 cells/mm3, AST \< 2 x upper limit of normal, Bilirubin \< 1.5 x upper limit of normal, Calculated creatinine clearance \> 30 cc/min by the Cockroft and Gault equation.
- Concurrent treatment with hormonal therapy or trastuzumab is allowed.
- Patients must be post-menopausal (either as a result of surgery, or amenorrhea for at least 12 consecutive months), or they must be practicing either abstinence, an adequate method of contraception (intrauterine device or barrier contraception), or their sexual partner must be sterile. Women who are pregnant, breast-feeding, or who are fertile and not practicing an adequate means of contraception will be excluded.
- Patients must have a central venous catheter.
- Patients must be able to give informed consent indicating that they are aware of the investigational nature of this study.
Exclusion
- No known CNS metastases.
- No treatment with cytotoxic chemotherapy allowed within 21 days of treatment with Aprotinin.
- No treatment with investigational agents allowed within 21 days of treatment with Aprotinin.
- No severe cardiovascular disease including unstable heart rhythm, uncompensated congestive heart failure, unstable angina or myocardial infarction within 6 months.
- No bleeding diathesis or coagulopathy including concomitant use of anticoagulants for thromboembolic disease
- No active anticoagulant therapy (including antiplatelet agents) for at least ten days.
- No active, uncontrolled bacterial, viral or fungal infection.
- No patients who are known or expected to be allergic to aprotinin, or who have received prior aprotinin.
- No patient with chronic systolic blood pressure (SBP) \< 90 mm Hg. If the (SBP) is \< 90 mm Hg on the day of treatment intravenous fluid may be administered to restore intravascular volume, if clinically indicated. In such case, if IV fluid corrects the SBP then the study drug may be given
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00354900
Start Date
July 1 2006
End Date
April 1 2007
Last Update
August 4 2009
Active Locations (1)
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1
Norris Cotton Cancer Center - Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756