Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00454571|
Recruitment Status : Completed
First Posted : March 30, 2007
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Prostate Cancer||Drug: pazopanib hydrochloride Drug: leuprolide acetate Drug: goserelin acetate||Phase 2|
I. Determine if pazopanib hydrochloride is able to increase time to progression, as measured by prostate-specific antigen (PSA), after 6 months of limited gonadotropin-releasing hormone (GnRH) agonist therapy comprising leuprolide acetate or goserelin in patients with androgen-sensitive relapsed stage D0 prostate cancer.
I. Determine the adverse events in patients treated with this regimen. II. To monitor for changes in testosterone in relationship to pazopanib therapy versus observation.
Patients receive androgen blockade comprising GnRH agonist therapy (e.g., leuprolide acetate or goserelin acetate) for 6 months. Patients who develop metastases or have PSA progression while on GnRH agonist therapy are removed from the study and placed on total androgen blockade. The remaining patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo observation.
After completion of study treatment, patients are followed up periodically for up to 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase II Study of GW786034 (Pazopanib) in Stage D0 Relapsed Androgen Sensitive Prostate Cancer Following Limited GnRH Agonist Therapy|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Other Names:Drug: leuprolide acetate
Other Names:Drug: goserelin acetate
Active Comparator: Observation
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
Drug: leuprolide acetate
Other Names:Drug: goserelin acetate
- Median Time to PSA Progression [ Time Frame: Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment ]The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.
- Median PSA Progression-free Survival [ Time Frame: Time from randomization to PSA progression or death from any cause ]Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test. The outcome measure is median PSA progression-free survival time.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454571
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Edwin Posadas||University of Chicago Comprehensive Cancer Center|