A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.

Study Overview

• Status: Terminated
• Conditions: Peritoneal Neoplasms; Ovarian Cancer
• Intervention / Treatment: Drug: Volociximab

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4N2
      • Tom Baker Cancer Center
    • Edmonton, Alberta, Canada, T6G1Z2
      • Cross Cancer Institute
  • Ontario
    • London, Ontario, Canada, NGA4L6
      • London Health Sciences Center
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill University Hospital
• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA JCCC Clinical Research Unit
    • Orange, California, United States, 92868-3201
      • UCI Medical Center
    • San Diego, California, United States, 92123
      • Sharp Hospital
  • Florida
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21231-1000
      • Johns Hopkins Kimmel Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic (MCMRC network)
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Science Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Mary Crowley Medical Research Center
    • Dallas, Texas, United States, 75231
      • Texas Oncology PA, Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
• Females aged ≥18 years old at the time of informed consent.
• Advanced (Stage III or IV), histologically-documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
• Radiologically-documented evidence of progressive disease.
• Platinum-resistant disease defined as having a best response of SD or disease progression during or within 6 months of discontinuing a platinum-based chemotherapy (carboplatinum, cisplatinum, or another organoplatinum compound).
• Progression during or following treatment with topotecan or liposomal doxorubicin.
• Three or fewer prior chemotherapy regimens (including a platinum-based therapy).
• At least 1 measurable target lesion in accordance with RECIST criteria to assess clinical response (tumors within a previously irradiated field are designated as non-target).
• ECOG Performance Status ≤1.
• Life expectancy >12 weeks.
• Available paraffin block or unstained paraffin sections on glass slides containing representative tumor tissue from the most recent tumor biopsy/resection.
• Subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment (about 5 half lives).

Exclusion Criteria:

• Screening clinical laboratory values:

  • Absolute neutrophil count <1500/µL
  • Platelet count <75,000/µL
  • Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion, erythropoietin, or other approved hematopoietic growth factors; darbopoeitin [Aranesp®] is permitted)
  • Serum bilirubin >2.0 x upper limit of normal (ULN)
  • AST and ALT >2.5 x ULN (AST and ALT >5 × ULN for subjects with liver metastasis)
  • Serum creatinine >2.0 mg/dL
  • International normalized ratio (INR) >1.5
  • Activated partial thromboplastin time (aPTT) >1.5 × ULN
• Clinically significant peripheral vascular disease.
• Non-epithelial ovarian tumors.
• Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.
• History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1.
• Serious, non-healing wound, or bone fracture.
• Known central nervous system or brain metastases.
• History of uncontrolled psychiatric condition within 6 months prior to Day 1.
• History of other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer.
• Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) sceloderma, or another diseases in which immune function or immune competence is known to be impaired.
• Any history of lymphoproliferative disorder.
• Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody (HACA).
• Any medical condition that may be exacerbated by bleeding, including a known bleeding disorder such as a coagulation defect, thrombocytopenia, active gastric or duodenal ulcer, or history of GI bleeding.
• Significant hemoptysis within one year prior to Study Day 1.
• Any investigational, anti-cancer therapy within 6 weeks prior to Day 1.
• Any non-investigational, anti-cancer therapy within 4 weeks prior to Day 1.
• Prior treatment with anti-angiogenic agents.
• Subjects who require treatment with an anti-coagulant with the exception of low-dose Aspirin® (≤81 mg/day), warfarin (≤1 mg/day), or heparin for IV catheter patency.
• Subjects who are taking concomitant immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low-dose methotrexate, or azathioprine. (The use of inhaled or intranasal steroids or oral steroids at a dose of ≤10 mg/day prednisone or its equivalent are permitted.)
• Active, unstable severe cardiovascular disease, including poorly controlled angina, congestive heart failure (CHF), arrhythmias, myocardial infarction (MI), cardiomyopathy, atrioventricular (AV) block, electrocardiogram (ECG) evidence of acute ischemia, or significant conduction abnormality.
• History of thromboembolic or cerebrovascular events, such as stroke, or transient ischemic attack (TIA). (Note: Prior history of deep vein thrombosis will not exclude subjects from participating in this study.)
• Pregnant (positive pregnancy test) or lactating.
• Inability to comply with study and follow-up procedures.
• Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
• Known hypersensitivity to murine or chimeric antibodies.
• Major surgery within 4 weeks prior to Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: volociximab; 15 mg/kg volociximab once weekly	Drug: Volociximab; 15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops; Other Names: M200

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria.	Baseline, and every 8 weeks on study

Collaborators and Investigators

• Sponsor: Facet Biotech
• Collaborators: Biogen
• Investigators: Principal Investigator: Carolyn Matthews, MD, Mary Crowley Medical Research Center; Principal Investigator: Minal Barve, MD, Texas Oncology PA, Presbyterian; Principal Investigator: James Burke, MD, Billings Clinic (MCMRC network); Principal Investigator: Dana Glenn, MD, Sharp Hospital; Principal Investigator: Russell Schilder, MD, Fox Chase Cancer Center; Principal Investigator: Nikki Spellman, MD, Indiana University; Principal Investigator: Michael Gold, MD, Oklahoma University Health Science Center; Principal Investigator: Richard Penson, MD, Massachusetts General Hospital; Principal Investigator: Mark Einstein, MD, Montefiore Medical Center; Principal Investigator: Robert Holloway, MD, Florida Hospital Cancer Institute; Principal Investigator: Deborah Armstrong, MD, Johns Hopkins Kimmel Cancer Center; Principal Investigator: Snehel Bhoola, MD, Memorial Health University Medical Center; Principal Investigator: Eric Winquist, MD, London Health Sciences Center; Principal Investigator: Ernst Lengyel, MD, University of Chicago; Principal Investigator: John Glaspy, MD, UCLA JCCC Clinical Research Unit; Principal Investigator: Krish Tewari, MD, UCI Medical Center; Principal Investigator: C. William Helm, MD, James Graham Brown Cancer Center; Principal Investigator: John Glaspy, MD, University of California, Los Angeles; Principal Investigator: Michael Sawyer, MD, Cross Cancer Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 14, 2007
• First Submitted That Met QC Criteria: August 15, 2007
• First Posted (Estimate): August 16, 2007

Study Record Updates

• Last Update Posted (Estimate): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: peritoneal cancer; epithelial ovarian cancer; platinum-resistant ovarian cancer; Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Abdominal Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Volociximab
• Other Study ID Numbers: 206OC201