| January 11, 2008 |
| January 22, 2008 |
| March 2007 |
| July 2008 (final data collection date for primary outcome measure) |
| Determination of progression-free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00599313 on ClinicalTrials.gov Archive Site |
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| Phase II Sunitinib Prog Met AIPC |
| Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-Based Chemotherapy |
The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer. |
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| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Metastatic Prostate Cancer |
| Drug: Sutent |
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| Active, not recruiting |
| 36 |
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| July 2008 (final data collection date for primary outcome measure) |
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
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| Male |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00599313 |
| Angelica McCallister, US Oncology Research |
| 2006-0012 |
| US Oncology Research |
| Pfizer |
| Principal Investigator: |
Guru Sonpavde, MD |
US Oncology Research |
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| US Oncology Research |
| January 2008 |