Status:
TERMINATED
Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer
Lead Sponsor:
New Mexico Cancer Research Alliance
Collaborating Sponsors:
Celgene Corporation
Conditions:
Ovarian Cancer
Epithelial Ovarian Cancer
Eligibility:
FEMALE
Phase:
PHASE1
Brief Summary
This study will test the feasibility of combining 3 drugs, Revlimid with Doxil and Bevacizumab,and gather preliminary data on the potential activity of the combination in patients with platinum resist...
Detailed Description
The combination of Doxil with Avastin has several aspects of interest to ovarian cancer treatment: 1) independent single-agent activity, 2) enhanced localization of Doxil is possible tumoral interstit...
Eligibility Criteria
Inclusion
- EOC patients must be platinum resistant/refractory (see 1.1 for definition) and be considered by the attending physician capable of being treated in this study according to GCP.
- Measurable disease by RECIST criteria or evaluable disease by GCIC criteria
- No prior anthracycline or lenalidomide use, unless the dose received was equal or less than one cycle and the patient did not progress on treatment.
- Subjects must have calculated creatinine clearance \> 60ml/min by Cockcroft-Gault formula during the escalation phase.
- Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula during the expansion phase. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance \> 30ml/min and \< 60ml/min.
- Understand and voluntarily sign an informed consent form.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
- No contraindication to anticoagulation
Exclusion
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Concurrent use of other anti-cancer agents or treatments.
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- History of thromboembolic event within the last 3 months
- Known hypersensitivity to any component of Avastin
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01202890
Start Date
September 1 2010
End Date
May 1 2012
Last Update
January 8 2014
Active Locations (1)
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1
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106