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| Study 1 of 1 for search of: | A Randomized, Phase II Study of GW786034 (Pazopanib) in Stage D0 Relapsed |
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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00454571 |
Purpose
RATIONALE: 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 leuprolide or goserelin, may lessen the amount of androgens made by the body. Giving pazopanib after leuprolide or goserelin may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying how well pazopanib works after leuprolide or goserelin in treating patients with relapsed prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: pazopanib hydrochloride Other: active surveillance |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomized, Phase II Study of GW786034 (Pazopanib) in Stage D0 Relapsed Androgen Sensitive Prostate Cancer Following Limited GnRH Agonist Therapy |
| Estimated Enrollment: | 98 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PSA and testosterone levels are measured monthly.
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Drug: pazopanib hydrochloride
given orally
|
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Arm II: No Intervention
Patients undergo observation. PSA and testosterone levels are measured monthly.
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Other: active surveillance
observation no treatment
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study.
Patients receive androgen blockade comprising gonadotropin-releasing hormone (GnRH) agonist therapy (e.g., leuprolide acetate or goserelin) for 6 months. Patients who develop metastases or have prostate-specific antigen (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.
Blood samples are collected at baseline and analyzed by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry for biological markers, including VEGFR1-3, PDGFRα, and PDGFRβ.
After completion of study treatment, patients are followed periodically for up to 12 months.
PROJECTED ACCRUAL: A total of 98 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed prostate cancer
Progressive disease meeting the following criteria:
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
No condition that impairs the ability to swallow and retain pazopanib hydrochloride tablets, including any of the following:
No other conditions, including any of the following:
New York Heart Association (NYHA) class III or IV heart failure
Systolic blood pressure (BP) ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg
PRIOR CONCURRENT THERAPY:
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:
No concurrent CYP2C9 substrates, including any of the following:
Anticoagulants (e.g., warfarin [therapeutic doses only])
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90089-9181 | |
| Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Joliet Oncology-Hematology Associates, Limited - West | Recruiting |
| Joliet, Illinois, United States, 60435 | |
| Contact: Sanjiv S. Modi, MD 815-730-3098 smod@jolietoncology.com | |
| Decatur Memorial Hospital Cancer Care Institute | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-6601 | |
| Evanston Hospital | Recruiting |
| Evanston, Illinois, United States, 60201-1781 | |
| Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Recruiting |
| Harvey, Illinois, United States, 60426 | |
| Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls 708-915-6747 | |
| Central Illinois Hematology Oncology Center | Recruiting |
| Springfield, Illinois, United States, 62701 | |
| Contact: Edem S. Agamah, MD, MS 217-525-2500 ihdn@aol.com | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
| Peoria, Illinois, United States, 61615-7828 | |
| Contact: Sachdev P. Thomas, MD 309-243-1000 sthomas@ohaci.com | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: David A. Taber, MD 574-647-3353 | |
| Fort Wayne Medical Oncology and Hematology | Recruiting |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Contact: Sreenivasa R. Nattam, MD 260-484-8830 ledgar@fwmoh.com | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
| United States, Michigan | |
| Oncology Care Associates, PLLC | Recruiting |
| Saint Joseph, Michigan, United States, 49085 | |
| Contact: Eric P. Lester, MD 269-985-0029 | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
| United States, Missouri | |
| David C. Pratt Cancer Center at St. John's Mercy | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J 314-251-6770 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
| Study Chair: | Edwin M. Posadas, MD | University of Chicago |
More Information
| Responsible Party: | University of Chicago Cancer Research Center ( Everett E. Vokes ) |
| Study ID Numbers: | CDR0000538086, UCCRC-14954A |
| Study First Received: | March 27, 2007 |
| Last Updated: | December 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00454571 History of Changes |
| Health Authority: | Unspecified |
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recurrent prostate cancer stage IV prostate cancer |
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Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |