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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00454571 (opens ClinicalTrials.gov in a new tab)Other idNCI-2009-00202Other idN01CM62201Other idCDR0000538086Other id14954A

Overview

Status
Completed
Phase
Phase 2
Enrollment
37 participants (actual)
Sponsor
National Cancer Institute (NCI) · Nih
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2006
Primary completion
Dec 2010
Completion
Dec 2010
First posted
30 Mar 2007 (estimated)
Last update posted
10 Feb 2016 (estimated)
Conditions
Recurrent Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. Ph 2

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

    NCT00454571

    Jun 2006 to Dec 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • pazopanib hydrochlorideDrug
  • leuprolide acetateDrug
  • goserelin acetateDrug

Arms2

  • Experimental

    Pazopanib

    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.

  • Active comparator

    Observation

    Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Median Time to PSA Progression

    Time frame · Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment

    Registry description

    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.

Secondary outcomes(1)
  1. Median PSA Progression-free Survival

    Time frame · Time from randomization to PSA progression or death from any cause

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment

Median Time to PSA Progression

GroupValue
Pazopanib, Leuprolide Acetate, and Goserelin Acetatenot posted
Leuprolide Acetate and Goserelin Acetate Onlynot posted
Secondary and other outcome results(1)
Secondary outcome· Time from randomization to PSA progression or death from any cause

Median PSA Progression-free Survival

GroupValue
Pazopanib, Leuprolide Acetate, and Goserelin Acetatenot posted
Leuprolide Acetate and Goserelin Acetate Onlynot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pazopanib, Leuprolide Acetate, and Goserelin AcetatePatients 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. pazopanib hydrochloride: Given PO leuprolide acetate goserelin acetate–5 / 1816 / 18
Leuprolide Acetate and Goserelin Acetate OnlyPatients undergo observation after treatment with leuprolide acetate and goserelin acetate. leuprolide acetate goserelin acetate–0 / 192 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultWard JE, Karrison T, Chatta G, Hussain M, Shevrin D, Szmulewitz RZ, O'Donnell PH, Stadler WM, Posadas EM. A randomized, phase II study of pazopanib in castrate-sensitive prostate cancer: a University of Chicago Phase II Consortium/Department of Defense Prostate Cancer Clinical Trials Consortium study. Prostate Cancer Prostatic Dis. 2012 Mar;15(1):87-92. doi: 10.1038/pcan.2011.49. Epub 2011 Oct 18. PMID 22006050

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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: * Gastrointestinal tract disease resulting in an inability to take oral medication * Requirement for intravenous (IV) alimentation * Prior surgical procedures affecting absorption * Active peptic ulcer disease * No other conditions, including any of the following: * Serious or nonhealing wound, ulcer, or bone fracture * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * Cerebrovascular accident within the past 6 months * Myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the past 6 months * Venous thrombosis within the past 12 weeks * New York Heart Association (NYHA) class III or IV heart failure * History of currently treated asymptomatic NYHA class II heart failure allowed * Systolic blood pressure (BP) ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg * Prior initiation or adjustment of BP medication allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg * More than 3 months since prior antiandrogen * More than 4 months since prior orchiectomy or implantable luteinizing LHRH agonist * No prior GnRH agonists except for neoadjuvant or adjuvant therapy associated with local therapy * Patients who have started a GnRH agonist for micrometastatic disease after local therapy allowed provided the following criteria are met: * Progressive disease * Willing to discontinue therapy before 6 months have elapsed * Have signed consent prior to completing 6 months of the initial hormone therapy * Are within 4 months of initiating GnRH agonist therapy * No prior or concurrent GnRH antagonist therapy * No concurrent ketoconazole * No concurrent cytochrome P450 2C9 (CYP2C9) substrates, including any of the following: * Anticoagulants (e.g., warfarin \[therapeutic doses only\]) * Low molecular weight heparin or prophylactic low-dose warfarin allowed * Oral hypoglycemics (e.g., glipizide, glyburide, tolbutamide, glimepiride, or nateglinide) * Ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, or methylergonovine) * Neuroleptics (e.g., pimozide) * Erectile dysfunction agents (e.g., sildenafil, tadalafil, or vardenafil) * Antiarrhythmics (e.g., bepridil, flecainide, lidocaine, mexiletin, amiodarone, quinidine, or propafenone) * Immune modulators (e.g., cyclosporine, tacrolimus, or sirolimus) * Miscellaneous medications (e.g., theophylline, quetiapine, risperidone, tacrine, clozapine, or atomoxetine) * No concurrent medications associated with the risk of QTc prolongation and/or Torsades de Pointes * Replacement of drugs that do not carry these risks allowed * No other concurrent non-Food and Drug Administration (FDA)-approved agents

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