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

Ovarian Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00516841
• Other study ID #: 206OC201
• Status: Terminated
• Phase: Phase 2
• First received: August 14, 2007
• Last updated: August 21, 2012
• Start date: August 2007
• Est. completion date: April 2008

Study information

• Verified date: August 2012
• Source: Facet Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

Drug:
• Volociximab
15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops

Locations

Country	Name	City	State
Canada	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
United States	Johns Hopkins Kimmel Cancer Center	Baltimore	Maryland
United States	Billings Clinic (MCMRC network)	Billings	Montana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of Chicago	Chicago	Illinois
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Texas Oncology PA, Presbyterian	Dallas	Texas
United States	Indiana University	Indianapolis	Indiana
United States	UCLA JCCC Clinical Research Unit	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Oklahoma University Health Science Center	Oklahoma City	Oklahoma
United States	UCI Medical Center	Orange	California
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Sharp Hospital	San Diego	California
United States	Memorial Health University Medical Center	Savannah	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Facet Biotech	Biogen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria.		Baseline, and every 8 weeks on study	No