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

NCT00454571 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00202N01CM62201CDR000053808614954A
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Median PSA Progression-free Survival

  Time from randomization to PSA progression or death from any cause

Study Arms (2)

Pazopanib

EXPERIMENTAL

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; Drug: leuprolide acetate; Drug: goserelin acetate

Observation

ACTIVE COMPARATOR

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

Drug: leuprolide acetate; Drug: goserelin acetate

Interventions

pazopanib hydrochloride DRUG

Given PO

Also known as: GW786034B, Votrient

Pazopanib

leuprolide acetate DRUG

Also known as: Enantone, LEUP, Lupron, Lupron Depot

Observation; Pazopanib

goserelin acetate DRUG

Also known as: ICI-118630, ZDX, Zoladex

Observation; Pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 22006050 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

pazopanib; Leuprolide; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Walter M. Stadler, MD
• Organization: The University of Chicago

wstadler@medicine.bsd.uchicago.edu

(773) 702-6149

Study Officials

• Edwin Posadas

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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: March 27, 2007
• First Posted: March 30, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 10, 2016
• Results First Posted: February 10, 2016

Record last verified: 2012-09

Locations

US (2)