Phase II Sunitinib Prog Met AIPC (NCT00599313) | Clinical Trial Compass
CompletedPhase 2
Phase II Sunitinib Prog Met AIPC
United States36 participantsStarted 2007-03
Plain-language summary
The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Median Progression-free Survival (PFS) Time at 1-year.