Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer
Primary Purpose
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Carcinoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide, Liposomal Doxorubicin, Bevacizumab
Revlimid, Doxil, Avastin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring lenalidomide, revlimid, liposomal doxorubicin, doxil, bevacizumab, avastin, platinum resistant ovarian cancer, 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
Sites / Locations
- University of New Mexico Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm 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.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies.
Secondary Outcome Measures
Progression-free survival (PFS) after treatment with Revlimid plus Avastin and Doxil.
Acute and subacute toxicities of Lenalidomide plus Doxil and Avastin for the treatment of ovarian cancer.
Full Information
NCT ID
NCT01202890
First Posted
September 14, 2010
Last Updated
January 7, 2014
Sponsor
New Mexico Cancer Care Alliance
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01202890
Brief Title
Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer
Official Title
Phase IB Study of Lenalidomide (Revlimid®) With Liposomal Doxorubicin (Doxil®) and Bevacizumab (Avastin®) for Patients With Platinum Resistant Ovarian Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to inadequate rate of accrual.
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
Keywords
lenalidomide, revlimid, liposomal doxorubicin, doxil, bevacizumab, avastin, platinum resistant ovarian cancer, ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide, Liposomal Doxorubicin, Bevacizumab
Other Intervention Name(s)
Revlimid, Doxil, Avastin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Revlimid, Doxil, Avastin
Intervention 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.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of the 3 drug combination and recommend a dose for phase II studies.
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) after treatment with Revlimid plus Avastin and Doxil.
Time Frame
6-8 Months
Title
Acute and subacute toxicities of Lenalidomide plus Doxil and Avastin for the treatment of ovarian cancer.
Time Frame
6-8 Months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Rutledge, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer
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