Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer

Completed · Phase 2

Conditions studied: Recurrent Prostate Cancer

In brief

This randomized phase II trial is studying how well pazopanib hydrochloride works after leuprolide or goserelin in treating patients with relapsed prostate cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate or goserelin acetate, may lessen the amount of androgens made by the body. Giving pazopanib after leuprolide or goserelin may be an effective treatment for prostate cancer

Key facts

Study ID

NCT00454571

Run by

National Cancer Institute (NCI)

People needed

37

Starts

2006-06-01

Expected to finish

2010-12-01

Last updated by the study team

2016-02-10

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed prostate cancer
• Stage D0
• Must have undergone some definitive local therapy for prostate cancer
• Must be free of macrometastatic disease, as evidenced by computed tomography (CT) scan and bone scan, if serum PSA ≥ 10 ng/mL prior to GnRH agonist therapy
• Progressive disease meeting the following criteria: NOTE: Patients who have undergone a prostatectomy and have two detectable, rising serum PSA levels are eligible
• Two consecutive rises in PSA above nadir recorded after definite local therapy
• Serum PSA concentrations must have absolute value of > 0.5 ng/mL (separated by ≥ 2 weeks) prior to beginning GnRH agonist therapy
• PSA < 0.5 ng/mL
• Testosterone < 30 ng/mL
• No measurable disease
• No brain metastases requiring steroid or anticonvulsant therapy
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60- 100%
• Prothrombin time (PT)/international normalization ratio (INR)/partial thromboplastin time (PTT) ≤ 1.2 times upper limit of normal (ULN)
• Bilirubin normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance > 50 mL/min
• Proteinuria ≤ 1+ on 2 consecutive dipsticks > 1 week apart
• Urine protein: creatinine ratio < 1 OR urine protein < 1.0 g/24 hours
• Fertile patients must use effective double-barrier contraception during study therapy OR completely abstain from sexual intercourse 14 days prior to, during, and for ≥ 21 days after completion of study therapy
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or to other agents used in the study
• No concurrent uncontrolled illness including, but not limited to, any of the following:
• Ongoing or active infection
• Psychiatric illness or social situations that would preclude compliance with study requirements
• No human immunodeficiency virus (HIV) positivity
• No condition that impairs the ability to swallow and retain pazopanib hydrochloride tablets, including any of the following:

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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