A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer
NCT ID: NCT00516841
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2007-08-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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volociximab
15 mg/kg volociximab once weekly
Volociximab
15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops
Interventions
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Volociximab
15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Biogen
INDUSTRY
Facet Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Carolyn Matthews, MD
Role: PRINCIPAL_INVESTIGATOR
Mary Crowley Medical Research Center
Minal Barve, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Oncology PA, Presbyterian
James Burke, MD
Role: PRINCIPAL_INVESTIGATOR
Billings Clinic (MCMRC network)
Dana Glenn, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp Hospital
Russell Schilder, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Nikki Spellman, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Michael Gold, MD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma University Health Science Center
Richard Penson, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Mark Einstein, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Robert Holloway, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Hospital Cancer Institute
Deborah Armstrong, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Kimmel Cancer Center
Snehel Bhoola, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Health University Medical Center
Eric Winquist, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Center
Ernst Lengyel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
John Glaspy, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA JCCC Clinical Research Unit
Krish Tewari, MD
Role: PRINCIPAL_INVESTIGATOR
UCI Medical Center
C. William Helm, MD
Role: PRINCIPAL_INVESTIGATOR
James Graham Brown Cancer Center
John Glaspy, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Michael Sawyer, MD
Role: PRINCIPAL_INVESTIGATOR
Cross Cancer Institute
Locations
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UCLA JCCC Clinical Research Unit
Los Angeles, California, United States
UCI Medical Center
Orange, California, United States
Sharp Hospital
San Diego, California, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Billings Clinic (MCMRC network)
Billings, Montana, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Texas Oncology PA, Presbyterian
Dallas, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
London Health Sciences Center
London, Ontario, Canada
McGill University Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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206OC201
Identifier Type: -
Identifier Source: org_study_id