We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Terminated due to inadequate rate of accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202890
First Posted: September 16, 2010
Last Update Posted: January 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
September 14, 2010
September 16, 2010
January 8, 2014
September 2010
May 2011   (Final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies. [ Time Frame: 6-8 months ]
To determine the Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies. [ Time Frame: 6-8 months ]
Complete list of historical versions of study NCT01202890 on ClinicalTrials.gov Archive Site
  • Progression-free survival (PFS) after treatment with Revlimid plus Avastin and Doxil. [ Time Frame: 6-8 Months ]
  • Acute and subacute toxicities of Lenalidomide plus Doxil and Avastin for the treatment of ovarian cancer. [ Time Frame: 6-8 Months ]
  • To assess progression-free survival (PFS) after treatment with Revlimid plus Avastin and Doxil. [ Time Frame: 6-8 Months ]
  • To determine the incidence of acute and subacute toxicities of Lenalidomide plus Doxil and Avastin for the treatment of ovarian cancer. [ Time Frame: 6-8 Months ]
Not Provided
Not Provided
 
Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
  • Drug: Lenalidomide, Liposomal Doxorubicin, Bevacizumab

    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.

    Other Name: Revlimid, Doxil, Avastin
  • Drug: Revlimid, Doxil, Avastin
    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.
Experimental: Arm 1
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.
Interventions:
  • Drug: Lenalidomide, Liposomal Doxorubicin, Bevacizumab
  • Drug: Revlimid, Doxil, Avastin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
May 2012
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01202890
INST 1001
No
Not Provided
Not Provided
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Celgene Corporation
Principal Investigator: Teresa Rutledge, MD University of New Mexico
New Mexico Cancer Care Alliance
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP