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Phase IB Study of Lenalidomide (Revlimid®) With Liposomal Doxorubicin (Doxil®) and Bevacizumab (Avastin®) for Patients With Platinum Resistant Ovarian Cancer.

Phase 1
Not Enrolling
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

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Trial Information

Phase IB Study of Lenalidomide (Revlimid®) With Liposomal Doxorubicin (Doxil®) and Bevacizumab (Avastin®) for Patients With Platinum Resistant 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.

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 <

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies.

Outcome Time Frame:

6-8 months

Safety Issue:


Principal Investigator

Teresa Rutledge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:

INST 1001



Start Date:

September 2010

Completion Date:

May 2012

Related Keywords:

  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
  • lenalidomide
  • revlimid
  • liposomal doxorubicin
  • doxil
  • bevacizumab
  • avastin
  • platinum resistant ovarian cancer
  • ovarian cancer
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636