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

New Mexico Cancer Care Alliance

Status and phase: Terminated; Phase 1

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

Treatments: Drug: Revlimid, Doxil, Avastin; Drug: Lenalidomide, Liposomal Doxorubicin, Bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01202890

INST 1001

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 1 patient

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Arm 1

Experimental group

Description:

At the expansion phase: Revlimid 20 mg (days 1-21), Doxil 30 mg/m2 on Day 1 and Avastin 15 mg/kg on Day 1, every 3 weeks. If this regimen is not cumulatively tolerable, Avastin will be administered every other course. Patients will be received up to 6 cycles or disease progression, followed by Revlimid maintenance at 25 mg PO q Day for 3 weeks every 4 weeks in patients with stable disease.

Treatment:

Drug: Revlimid, Doxil, Avastin

Drug: Lenalidomide, Liposomal Doxorubicin, Bevacizumab