Phase 2
Completed N=23
Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Hormone-Resistant Prostate Cancer · Recurrent Prostate Carcinoma
Source: ClinicalTrials.gov NCT00486642 ↗
Enrolled (actual)
23
Serious AEs
21.7%
Results posted
May 2017
Primary outcomePrimary: PSA Response Rate — 1; 2 Participants
Summary
This randomized phase II trial is studying how well giving pazopanib with or without bicalutamide works in treating patients with prostate cancer that did not respond to hormone therapy. Pazopanib 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 bicalutamide, may lessen the amount of androgens made by the body. Giving pazopanib hydrochloride together with bicalutamide may be an effective treatment for prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PSA Response Rate |
1; 2 | — |
| SECONDARY Objective Tumor Response Rate as Assessed by RECIST Criteria |
0; 1 | — |
| SECONDARY Progression-free Survival |
7.3; 11.3 | — |
| SECONDARY Median Duration of PSA-Response |
8.3; 13.1 | — |
| SECONDARY Stable Disease Rate as Assessed by RECIST Criteria |
2; 8 | — |
| SECONDARY Time to Disease Progression |
7.3; 11.3 | — |
| SECONDARY Toxicity |
3; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed prostate cancer
- Must have received prior hormonal therapy, including either medical (luteinizing hormone-releasing hormone [LHRH] agonist) or surgical (orchiectomy) castration
- Castrate level of testosterone ( = 5 ng/mL
- No known brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 3 months
- White blood cell (WBC) >= 3,000/mm^3
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- International normalized ratio (INR) = = 60 mL/min
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or bicalutamide
- Proteinuria = = 1 week apart
- QTc 150 mm Hg or diastolic BP > 90 mm Hg)
- No condition (e.g., gastrointestinal [GI] tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation; prior surgical procedures affecting absorption; or active peptic ulcer disease) that impairs the ability to swallow and retain pazopanib hydrochloride tablets
- No serious or nonhealing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within the past 28 days
- No cerebrovascular accident within the past 6 months
- No myocardial infarction, cardiac arrhythmia, admission for unstable angina, cardiac angioplasty, or stenting within the past 12 weeks
- No venous thrombosis within the past 12 weeks
- No New York Heart Association (NYHA) class III-IV heart failure
- Patients with a history of NYHA class II heart failure who are asymptomatic on treatment are eligible
- No concurrent uncontrolled illness, including, but not limited to, ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- Recovered from all prior therapy
- Prior neoadjuvant or adjuvant chemotherapy allowed
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
- At least 4 weeks since prior antiandrogens
- At least 4 weeks since prior surgery
- No prior bicalutamide therapy lasting > 3 months in duration
- Concurrent steroids allowed if no change in steroid dosage within the past 4 weeks
- No other concurrent investigational agents
- No concurrent therapeutic warfarin
- Concurrent low molecular weight heparin or prophylactic low-dose warfarin allowed
- No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
Data sourced from ClinicalTrials.gov (NCT00486642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.