Ovarian Cancer Clinical Trial
Official title:
Phase IB Study of Lenalidomide (Revlimid®) With Liposomal Doxorubicin (Doxil®) and Bevacizumab (Avastin®) for Patients With Platinum Resistant Ovarian Cancer.
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | May 2012 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
New Mexico Cancer Care Alliance | Celgene Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies. | 6-8 months | No | |
Secondary | Progression-free survival (PFS) after treatment with Revlimid plus Avastin and Doxil. | 6-8 Months | No | |
Secondary | Acute and subacute toxicities of Lenalidomide plus Doxil and Avastin for the treatment of ovarian cancer. | 6-8 Months | Yes |
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