study of revlimid with doxil and avastin for patients with platinum resistant ovarian cancer

Conditions: Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma

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.

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 interstitial pressure via increased half-life (if liposomal egress is diminished) and decreased \[42\], 3) improved doxil distribution, and 4) likely favorable toxicity profile since doxil's only common problematic toxicity is to the skin (palmar-plantar erythrodysesthesia or ppe). lenalidomide has also antiangiogenic properties, with a different mechanism of action than avastin. given the preliminary results of the effect of the combination of doxil with avastin, showing an increase in progression-free survival, we are interested in using a new thalidomide analog to maximize the angiogenic inhibition. this study will test the feasibility of combining all 3 drugs, and gather preliminary data on the potential activity of the combination in patients with platinum resistant/refractory ovarian cancer.

Eligibility 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

Keywords: lenalidomide revlimid liposomal doxorubicin doxil bevacizumab avastin platinum resistant ovarian cancer ovarian cancer