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Phase II Sunitinib Prog Met AIPC
This study is ongoing, but not recruiting participants.
First Received: January 11, 2008   Last Updated: January 22, 2008   History of Changes
Sponsor: US Oncology Research
Collaborator: Pfizer
Information provided by: US Oncology Research
ClinicalTrials.gov Identifier: NCT00599313
  Purpose

The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.


Condition Intervention Phase
Metastatic Prostate Cancer
Drug: Sutent
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • Determination of progression-free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2007
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sutent
    50 mg/day orally each of Days 1-28 of each 6 week cycle
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A patient will be eligible for inclusion in this study if he meets all of the following criteria:
  • Histologically confirmed, adenocarcinoma of the prostate
  • Stage IV(metastatic) disease, documented on CT, MRI, or X-ray
  • Progressive disease (PSA or clinical): PSA progression defined as baseline increase followed by any serial increase after 2 weeks; clinical progression by symptomatic or radiologic criteria.
  • An elevated PSA level of for patients progressing by PSA criteria is required
  • Currently on androgen ablation hormone therapy (an LHRH agonist or orchiectomy) with testosterone level <50ng/dL)
  • Has received 1 or 2 prior chemotherapy regimens (no more than 2). One prior regimen must be docetaxel.
  • Has an ECOG Performance Status (PS) 0-2
  • Is greater than 18 years of age
  • Meets protocol defined laboratory values
  • Has adequate cardiac function in the opinion of the Investigator
  • Has no uncontrolled arrhythmia or hypertension
  • Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE Version 3.0 Grade less than 1, in the opinion of the Treating Physician
  • If fertile, patient has agreed to use an acceptable method of birth control to prevent pregnancy for the duration of the study and for a period of 2 months thereafter
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form

Exclusion Criteria:

  • A patient will be excluded from this study if he meets any of the following criteria:
  • Has any disease other than that described in inclusion criterion #1
  • Had prior treatment with Sutent
  • Has not received prior docetaxel for the current disease
  • Has received any prior radionuclide therapy
  • Has received prior radiation to >50% of the bone marrow
  • Is receiving concurrent immunotherapy
  • Has a history of hypersensitivity to any of the components of Sutent: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients. The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The caramel gelatin capsule shells also contain yellow iron oxide and black iron oxide. The printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide.
  • Has had significant bleeding in previous 4 weeks
  • Has had any of the following within the prior 6 months: severe/unstable angina, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism
  • Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult
  • Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 4 weeks prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
  • Has uncontrolled arrhythmia or hypertension
  • Has evidence of uncontrolled CNS involvement (previous radiation and off steroids is acceptable)
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
  • Is unable to comply with requirements of study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599313

  Hide Study Locations
Locations
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
United States, Connecticut
Connecticut Oncology & Hematology, LLP
Torrington, Connecticut, United States, 06790
United States, Florida
Ocala Oncology Center
Ocala, Florida, United States, 34474
United States, Illinois
Cancer Care & Hematology Specialista of Chicagoland
Niles, Illinois, United States, 60714
United States, Indiana
Hope Center
Terre Haute, Indiana, United States, 47802
United States, Maryland
Alliance Hematology Oncology PA
Westminster, Maryland, United States, 21157
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
United States, Missouri
St. Joseph Oncology, Inc.
St Joseph, Missouri, United States, 64507
Arch Medical Services, Inc. DBA The Cntr for Cancer Care & Research
St. Louis, Missouri, United States, 63141
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
NH Oncology-Hematology PA
Hooksett, New Hampshire, United States, 03106
United States, New Mexico
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Interlakes Oncology Hematology, PC
Rochester, New York, United States, 14623
United States, North Carolina
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Ohio
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, Pennsylvania
Medical Oncology Associates
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology Cancer Care and Research
Waco, Texas, United States, 76712
Texas Oncology, P.A.-Bedford
Bedford, Texas, United States, 76022
Texas Cancer Center
Arlington, Texas, United States, 76014
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States, 75237
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, United States, 79106
HOAST-Medical Dr.
San Antonio, Texas, United States, 78229
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
El Paso Cancer Treatment Ctr
EL Paso, Texas, United States, 79915
Paris Regional Cancer Center
Paris, Texas, United States, 75460
Texas Oncology-Odessa
Odessa, Texas, United States, 79761
Texas Onclogy, P.A.
Dallas, Texas, United States, 75231
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702
Texas Cancer Center-Abilene(South)
Abilene, Texas, United States, 79606
Texas Cancer Center
Denton, Texas, United States, 76210
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
Texas Oncology, P.A.
Webster, Texas, United States, 77598
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, United States, 77479
Allison Cancer Center
Midland, Texas, United States, 79701
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States, 24153
United States, Washington
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States, 98902
Puget Sound Cancer Center-Seattle
Seattle, Washington, United States, 98133
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, United States, 98026
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
US Oncology Research
Pfizer
Investigators
Principal Investigator: Guru Sonpavde, MD US Oncology Research
  More Information

No publications provided

Responsible Party: US Oncology Research ( Angelica McCallister )
Study ID Numbers: 2006-0012
Study First Received: January 11, 2008
Last Updated: January 22, 2008
ClinicalTrials.gov Identifier: NCT00599313     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009