Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

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 resistant/refractory ovarian cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Collaborator: Celgene Corporation
• Treatments: Bevacizumab; Doxorubicin; Lenalidomide; Liposomal doxorubicin; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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