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

Stopped early · Phase 2

Conditions studied: Ovarian Cancer, Peritoneal Neoplasms

In brief

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.

Key facts

Study ID

NCT00516841

Run by

Facet Biotech

People needed

16

Starts

2007-08-01

Expected to finish

2008-04-01

Last updated by the study team

2012-08-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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