Status:
COMPLETED
Study of SU11248 in Men With Advanced Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
United States Department of Defense
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
* There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments. * SU011248 is an exciting, n...
Detailed Description
Background: There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new therapeutics. The mainstay of therapy...
Eligibility Criteria
Inclusion
- Signed informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
- Adenocarcinoma of the prostate
- Male subjects, 18 years of age or older
- Life expectancy of \> 12 weeks
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedure to National Cancer Institute Common Toxicity Criteria Adverse Event (NCI CTCAE) grade \<1
- Surgical or ongoing chemical castration
- Androgen-independent disease, defined as progressive disease despite surgical or ongoing chemical castration. See section 8.2.3 for definition of progressive disease.
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- Adequate bone marrow reserve:
- Neutrophil count \> 1,500/ul
- Platelet count \> 75,000/ul
- Adequate hepatic function:
- Serum bilirubin \< 1.5 x upper limit of normal
- Asparate aminotransferase and alanine aminotransferase \< 2.5 x upper limit of normal
- Adequate renal function, with serum creatinine \< 2 x upper limit of normal
- Prostate Specific Antigen (PSA) \> 5.0 ng/mL, based on PSA Working Group Criteria
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- For Group A only:
- · No prior treatment for prostate cancer with cytotoxic chemotherapy
- For Group B only:
- Radiographic evidence of metastatic prostate cancer
- One prior docetaxel-based chemotherapy regimen, minimum of two cycles
- Disease progression during treatment with docetaxel, or within 60 days of receiving docetaxel
Exclusion
- Small cell carcinoma of the prostate
- Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry.
- Any of the following within the prior 6 months: unstable angina, myocardial infarction, symptomatic congestive heart failure or cerebrovascular accident
- Receipt of any investigational anti-cancer agent within 4 weeks of the study
- NCI CTCAE grade 3 hemorrhage \< 4 weeks of starting study treatment
- Uncontrolled hypertension
- Prolongation of the QTc interval to \> 450 msec
- Other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00299741
Start Date
March 1 2006
End Date
June 1 2008
Last Update
December 19 2012
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115