Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase 2 Study of GW786034 (Pazopanib) With or Without Bicalutamide in Hormone Refractory Prostate Cancer
8 other identifiers
interventional
23
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2007
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
May 24, 2017
CompletedMay 24, 2017
April 1, 2017
7.9 years
June 13, 2007
October 14, 2015
April 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
PSA Response Rate
Prostate-specific antigen (PSA) response rate (defined as a confirmed \> / = 50% decline (minimum 5ng/ml) in PSA from baseline maintained for \>4 weeks, and without other evidence of disease progression documented at time of confirmatory values).
Up to 12 weeks
Secondary Outcomes (6)
Objective Tumor Response Rate as Assessed by RECIST Criteria
Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years
Progression-free Survival
From time of treatment initiation to disease progression or death from any cause, whichever came first, assessed up to 5 years
Median Duration of PSA-Response
From time PSA response criteria are met until time PSA progression criteria are met or death from any cause, whichever came first, up to 5 years
Stable Disease Rate as Assessed by RECIST Criteria
Measured from the start of the treatment until the criteria for progression are met or death from any cause, whichever came first, assessed up to 5 years
Time to Disease Progression
Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years
- +1 more secondary outcomes
Other Outcomes (2)
Median Survival Time
Up to 1 year after completion of treatment
Survival Rate
At 1 year
Study Arms (2)
Arm A (pazopanib hydrochloride)
EXPERIMENTALPatients receive pazopanib hydrochloride PO QD on days 1-28. .
Arm B (pazopanib hydrochloride, bicalutamide)
EXPERIMENTALPatients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Interventions
Given PO
Correlative studies
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- 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 (\< 50 ng/dL)
- Patients treated with LHRH agonists must continue or restart this therapy
- Must have radiological documentation of either measurable or non-measurable disease
- Must show documented progression of prostate cancer while on hormonal therapy as indicated by PSA increase
- Rising PSA is defined as ≤ 2 consecutive rises in PSA taken ≥ 1 week and ≤ 2 months apart
- PSA \>= 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) =\< 1.2
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Sridhar SS, Joshua AM, Gregg R, Booth CM, Murray N, Golubovic J, Wang L, Harris P, Chi KN. A phase II study of GW786034 (pazopanib) with or without bicalutamide in patients with castration-resistant prostate cancer. Clin Genitourin Cancer. 2015 Apr;13(2):124-9. doi: 10.1016/j.clgc.2014.06.001. Epub 2014 Jun 8.
PMID: 24993934DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kim N. Chi
- Organization
- Bristish Columbia Cancer Agency
Study Officials
- PRINCIPAL INVESTIGATOR
Kim Chi
University Health Network-Princess Margaret Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2007
First Posted
June 14, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
May 24, 2017
Results First Posted
May 24, 2017
Record last verified: 2017-04