Phase II Sunitinib Prog Met AIPC

Completed · Phase 2

Conditions studied: Metastatic Prostate Cancer

In brief

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

Key facts

Study ID: NCT00599313
Run by: US Oncology Research
People needed: 36
Starts: 2007-03-01
Expected to finish: 2009-06-01
Last updated by the study team: 2018-10-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Hematology Oncology Associates — Phoenix, Arizona, United States
Connecticut Oncology & Hematology, LLP — Torrington, Connecticut, United States
Ocala Oncology Center — Ocala, Florida, United States
Cancer Care & Hematology Specialista of Chicagoland — Niles, Illinois, United States
Hope Center — Terre Haute, Indiana, United States
Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
Alliance Hematology Oncology PA — Westminster, Maryland, United States
Missouri Cancer Associates — Columbia, Missouri, United States
St. Joseph Oncology, Inc. — Saint Joseph, Missouri, United States
Arch Medical Services, Inc. DBA The Cntr for Cancer Care & Research — St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
NH Oncology-Hematology PA — Hooksett, New Hampshire, United States
New Mexico Cancer Care Associates — Santa Fe, New Mexico, United States
New York Oncology Hematology, P.C. — Albany, New York, United States
Interlakes Oncology Hematology, PC — Rochester, New York, United States
Cancer Centers of North Carolina — Raleigh, North Carolina, United States
Greater Dayton Cancer Center — Kettering, Ohio, United States
Medical Oncology Associates — Kingston, Pennsylvania, United States
Cancer Centers of the Carolinas — Greenville, South Carolina, United States
Texas Cancer Center-Abilene(South) — Abilene, Texas, United States
Texas Oncology, P.A.-Amarillo — Amarillo, Texas, United States
Texas Cancer Center — Arlington, Texas, United States
Texas Oncology Cancer Center — Austin, Texas, United States
Mamie McFaddin Ward Cancer Center — Beaumont, Texas, United States
Texas Oncology, P.A.-Bedford — Bedford, Texas, United States

Full record on ClinicalTrials.gov

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