Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research.

This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy.

Patients must meet the study eligibility criteria and must be competent to give informed consent.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: Peregrine Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Bavituximab

Criteria

Inclusion Criteria:

• Written informed consent has been obtained.

• Adults 18 years of age or older with a life expectancy of at least 3 months.

• Histologically confirmed castration-resistant prostate cancer (CRPC). Patient must have demonstrated a rising PSA level above the androgen-deprivation therapy (ADT) nadir, on at least two determinations four weeks or more apart. ADT is defined as treatment with a Luteinizing-hormone-releasing hormone (LHRH) agonist or orchiectomy.

• Treatment with only one prior chemotherapy regimen, which must contain docetaxel as a single agent or in combination with other agents. Patients may be intolerant of, or resistant to, the cytotoxic drug combination.

• Patients on ADT must be willing to continue ADT for the duration of their participation in this protocol. ADT cannot be initiated, and ADT dose/agents may not be changed during the study.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

• Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 8 g/dL, platelets ≥ 100,000/μL).

• Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).

• Adequate hepatic function (bilirubin ≤ 1.0 x upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN, aspartate aminotransferase [AST] ≤ 1.5 x ULN).

• Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 × ULN.

• Activated partial thromboplastin (aPTT) time ≤ 1.5 × ULN.

• Prostate-specific antigen (PSA) level of at least 2 ng/mL.

• New York Heart Association classification I or II.

• All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).

Exclusion Criteria:

• Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).

• Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis > 6 months before Screening is allowed.

• Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of central venous catheters are eligible.

• Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities).

• Radiotherapy (teletherapy or brachytherapy) , chemotherapy or estrogen agonist within 28 days before Study Day 1.

• Systemic radiotherapy (Sm-153, Sr-89) within 56 days before study day 1.

• Symptomatic or clinically active brain metastases.

• Major surgery within 28 days of Study Day 1.

• Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease).

• Any history of cerebrovascular accident, or transient ischemic attack at any time, or history of symptomatic coronary artery disease < 6 months before screening.

• A history of any condition requiring anti-platelet therapy (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), with the exception of general cardiovascular prophylaxis with aspirin (≤ 325 mg/day).

• Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture).

• Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.

• Contraindication to intravenous (IV) contrast media.