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

NCT01202890 | Terminated Phase 1

• 1 other identifier: INST 1001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  6-8 months

Secondary Outcomes (2)

• Progression-free survival (PFS) after treatment with Revlimid plus Avastin and Doxil.

  6-8 Months

• Acute and subacute toxicities of Lenalidomide plus Doxil and Avastin for the treatment of ovarian cancer.

  6-8 Months

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

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

Interventions

Lenalidomide, Liposomal Doxorubicin, Bevacizumab DRUG

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.

Also known as: Revlimid, Doxil, Avastin

Arm 1

Revlimid, Doxil, Avastin DRUG

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.

Arm 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Lenalidomide; liposomal doxorubicin; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Teresa Rutledge, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

US (1)