AzTrials
AzTrials

Recurrent Prostate CancerPhase 2NCT00454571

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

A Phase 2 study testing pazopanib hydrochloride, leuprolide acetate and goserelin acetate in people with Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Recurrent Prostate Cancer
What is being tested?
pazopanib hydrochloride, leuprolide acetate and goserelin acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
Jun 2006to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 62Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Randomized, Phase II Study of GW786034 (Pazopanib) in Stage D0 Relapsed Androgen Sensitive Prostate Cancer Following Limited GnRH Agonist Therapy

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

SECONDARY OBJECTIVES:

  1. Determine the adverse events in patients treated with this regimen. II. To monitor for changes in testosterone in relationship to pazopanib therapy versus observation.

OUTLINE:

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.

Being tested
pazopanib hydrochloride, leuprolide acetate, goserelin acetate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pazopanib hydrochlorideDrug

    Also called GW786034B, Votrient

    Given PO

  • leuprolide acetateDrug

    Also called Enantone, LEUP, Lupron, Lupron Depot

  • goserelin acetateDrug

    Also called ICI-118630, ZDX, Zoladex

Study groups in NCT00454571
Study groupRoleWhat they receive
PazopanibExperimentalPatients 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.
Receives: Drug: pazopanib hydrochloride; Drug: leuprolide acetate; Drug: goserelin acetate
ObservationActive comparatorPatients undergo observation after treatment with leuprolide acetate and goserelin acetate.
Receives: Drug: leuprolide acetate; Drug: goserelin acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Time to PSA Progression

    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.

    Measured: Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment

Secondary outcomes (1)

  1. Median PSA Progression-free Survival

    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.

    Measured: Time from randomization to PSA progression or death from any cause

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2007 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00454571
Sponsor's protocol ID
NCI-2009-00202
Other IDs
N01CM62201, CDR0000538086, 14954A
Status last verified
Sep 2012
First submitted
27 Mar 2007
Last updated
10 Feb 2016
Data monitoring committee
Yes

Publications

  • Ward 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.

    PubMed 22006050

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib hydrochloride, leuprolide acetate and goserelin acetate in people with Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 62 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Time to PSA Progression (time frame: Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00454571, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in