Pazopanib as Second Line Therapy in Patients With Metastatic Prostate Cancer Refractory to Total Androgen Blockade

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

A growing body of literature supports the role of angiogenesis in the development and spread of a variety of human cancers including prostate cancer. * Vascular endothelial growth factor (VEGF) expression is low in normal prostate tissue, but markedly increased in tumor tissues, and has a positive association with tumor stage and grade * Plasma VEGF levels are significantly elevated in patients with hormone refractory prostate cancer (HRPC) compared to those patients with localized disease and have been associated with disease progression in other cancer patient population. * The Cancer and Leukemic Group-B demonstrated that VEGF levels correlate with survival. Pazopanib is a potent multi-target receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors.

Key facts

Study ID

NCT00945477

Run by

Illinois CancerCare, P.C.

People needed

11

Starts

2009-07-01

Expected to finish

2012-10-01

Last updated by the study team

2013-11-18

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of adenocarcinoma of the prostate histology, currently on total androgen blockage with a bicalutamide.
• Subjects must provide written informed consent prior to administration of pazopanib or the performance of any study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol. Note: It is not necessary that informed consent be obtained within the protocol-specified screening window.
• Received no prior second line hormone therapy or any chemotherapy. No prior bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic prostate cancer.
• Must have metastatic diagnosis, meaning disease beyond the prostate gland.
• A progressing PSA of ≥ 3, the PSA will be measured in ≥ 14 days.
• KPS of ≥ 70
• Age ≥ 18 years old
• Adequate organ system functions:
• Absolute neutrophil count (ANC) ≥ 1.5 X 109/L
• Hemoglobin ≥ 9 g/dL
• Platelets ≥ 100 X 109/L
• International normalized ratio (INR) ≤ 1.2 X upper limit of normal (ULN)
• Partial thromboplastin time (PTT) ≤ 1.2 X ULN
• Total bilirubin ≤ 1.5 X ULN
• AST and ALT ≤ 2.5 X ULN
• Calculated creatinine clearance ≥ 30 mL/min
• Urine Protein to Creatinine Ratio (UPC)2 < 1
• Total serum calcium concentration < 12.0mg/dL
• Subjects may not have had a transfusion within 7 days of screening assessment.
• If UPC ≥ 1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value < 1 g to be eligible.
• Left ventricular ejection fraction (LVEF) ≥ 55% as assessed by echocardiography or multigated acquisition (MUGA) scan. The same modality used at baseline must be applied for subsequent evaluations.

You may not qualify if…

• Subjects meeting any of the following criteria must not be enrolled in the study:
• History of another malignancy.
• Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• History or clinical evidence of central nervous system (CNS) metastases.
• Note: Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
• Are asymptomatic and,
• Have had no evidence of active CNS metastases for ≥ 6 months prior to enrollment and,
• Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC).
• Clinically significant gastrointestinal abnormalities including, but not limited to:
• Malabsorption syndrome,
• Major resection of the stomach or small bowel that could affect the absorption of study drug,
• Active peptic ulcer disease,
• Inflammatory bowel disease,
• Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation,
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
• Presence of uncontrolled infection.
• Prolongation of corrected QT interval (QTc) > 480 milliseconds (msecs).
• History of any one or more of the following cardiovascular conditions within the past 12 months:
• Cardiac angioplasty or stenting,
• Myocardial infarction,
• Unstable angina,
• Symptomatic peripheral vascular disease,
• Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
• History of cerebrovascular accident (CVA) including transient ischemic attack (TIA).
• History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible.

Where it is running

• Illinois CancerCare — Bloomington, Illinois, United States
• Illinois CancerCare — Ottawa, Illinois, United States
• Illinois CancerCare — Pekin, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States

Full record on ClinicalTrials.gov

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