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

This study has been terminated.
(Decision to terminate recruitment based on lack of efficacy)
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00516841
First received: August 14, 2007
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Neoplasms
Drug: Volociximab
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Primary Outcome Measures:
  • Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria. [ Time Frame: Baseline, and every 8 weeks on study ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: M200

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516841

  Show 23 Study Locations
Sponsors and Collaborators
Facet Biotech
Biogen Idec
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
  More Information

No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00516841     History of Changes
Other Study ID Numbers: 206OC201
Study First Received: August 14, 2007
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
epithelial ovarian cancer
peritoneal cancer
platinum-resistant ovarian cancer
Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

Additional relevant MeSH terms:
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Digestive System Diseases
Peritoneal Diseases
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014