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

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer; Prostatic Neoplasms

Intervention: Cabazitaxel plus bavituximab (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Michael Lilly, MD, Principal Investigator, Affiliation: Medical University of South Carolina

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.

Clinical Details

Official title: Phase Ib/IIa Study of Cabazitaxel Plus Bavituximab for Patients With Castration-resistant Prostate Cancer Previously Treated With Chemotherapy

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

Primary outcome: Probability of progression-free survival at day 85

Secondary outcome:

Measurement of PSA response rate

Objective response rate by RECIST for patients with measurable disease

Overall survival

Grade 3 or 4 Toxicity

Progression-free survival (PFS)

Detailed description: Cabazitaxel will be administered IV on day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an intravenous (IV) infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8, day 15). Patients will receive cabazitaxel (day 1) plus bavituximab weekly of each 21-day cycle for up to 8 cycles. Up to 31 patients will be enrolled to ensure 28 evaluable subjects. The accrual period is expected to be between 12 to 18 months (1-1. 5 years). Subjects will remain on the treatment phase of the study until any of the following events occur:

- Disease progression as evidenced by an increase in the prostate-specific antigen (PSA)

level, worsening of pain, or disease progression by Response Evaluation Criteria in Solid Tumors (RECIST)

- Completion of 8 cycles of cabazitaxel-bavituximab therapy (day 169)

- Development of toxicity that, in the investigator's judgment, precludes further study

participation

- Significant protocol violations or noncompliance on the part of the patient or

investigator

- The investigator's judgment that discontinuation is in the patient's best interest

- Initiation of alternative antineoplastic treatments.

- Refusal of the patient to continue treatment or follow-up

- Loss to follow-up

After completion of the treatment phase, subjects will remain on the followup phase of the study until any of the following events occur:

- Refusal of the patient to continue treatment or follow-up

- Loss to follow-up

- Death

- The investigator's judgment that discontinuation is in the patient's best interest

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information

Starting date: June 2011
Last updated: March 20, 2013

Page last updated: August 23, 2015

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