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Last reviewed: 7 August 2006. Last updated: 7 August 2006 gs.
University of Washington Health Sciences
Research Studies Seeking Volunteers
Reference: 20060381
Study Title:
A Phase II, Multicenter, Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 3 –Hour IV Infusion Every 2 Weeks, In Relapsing Or Refractory Patients With Androgen-Independent Prostate Adenocarcinoma
Study Description:
The purpose of this study is to determine whether or not an investigational drug called Aplidin is safe and effective at controlling metastatic prostate cancer that has not responded adequately to prior hormone therapy.
Participants may be in the study for up to about 6 months, not including screening exams to see if they are eligible.
Participants will receive an infusion of Aplidin once every 2 weeks. Each infusion lasts approximately 3 hours, and is given through a vein (intravenously). Participants will also have regularly scheduled blood draws, bone scans and CT scans.
Eligibility Criteria:
1. Men with metastatic prostate cancer that no longer responds to hormone treatment and is getting worse, as evidenced by rising PSA and worsening bone or CT scans.
2. Patient is 18 years of age or older.
3. Patient must have received prior chemotherapy with docetaxel (also called Taxotere)
4. Patient has recovered from any toxicity derived from previous treatments.
5. Patient has adequate heart function.
6. Patient must have stopped prior therapy:
• at least 6 weeks before starting this study, if treated with nitroso-urea or high dose chemotherapy
• at least 4 weeks before starting this study, if treated with other chemotherapies or biological agents
• at least 6 weeks before starting this study, if treated with extensive external beam
Exclusions (conditions that would prevent a volunteer from participating in this study):
1. Other current anti-cancer therapy.
2. More than 2 previous types of systemic therapy (biologic or chemotherapy).
3. History of another cancer with the exception of:
- Non-melanoma skin cancer.
- Any other cancer that has been successfully treated, with no evidence of disease for at least 10 years.
4. History of significant heart problem, or other clinically significant problems.
Location:
Most of the treatment will be given at the Seattle Cancer Care Alliance (SCCA) outpatient clinic. If hospitalization is needed while in Seattle, participants will be admitted to the University of Washington Medical Center (UWMC).
Principal Investigator:
Celestia Higano, MD
School of Medicine
For further information about this study, please contact:
Peggy Pitzel, RN, Study Coordinator
206-288-2171