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Sponsored by: |
British Columbia Cancer Agency |
Information provided by: | British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT00407251 |
The purpose of this study is to determine the efficacy of patupilone chemotherapy and to find out what effects (good and bad) the drug Patupilone has on patients with prostate cancer that has progressed following hormone treatment and docetaxel chemotherapy.
Condition | Intervention | Phase |
Hormone Refractory Prostate Cancer |
Drug: Patupilone |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Docetaxel Epothilone B |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Patupilone (EPO906A) as a Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 73 |
Study Start Date: | February 2007 |
Prostate cancer is the most common cancer diagnosed and the second most common cause of cancer death in men in North America (Jemal 2003). Many patients with localized disease have an excellent long-term survival and high cure rates with standard approaches (D'Amico 1998). However, patients with high risk, locally advanced and metastatic disease have a poor prognosis, and although hormonal therapy in the form of medical or surgical castration can induce significant long-term remissions,development of androgen independent disease is inevitable. Androgen independent (AI) disease, also termed hormone refractory prostate cancer (HRPC), is clinically detected by a rise in prostate specific antigen (PSA) and worsening of symptoms. Once patients reach this stage, therapeutic options are limited and prognosis is poor
Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no treatment has been proven to be efficacious. Because of the mechanism of action and the activity of anti-microtubule agents and combinations in general for HRPC, patupilone has potential for therapeutic activity in patients with HRPC that have progressed after first line docetaxel chemotherapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kim Chi, MD | 604-877-6000 ext 2746 | kchi@bccancer.bc.ca |
Canada, Alberta | |||||
Tom Baker Cancer Centre | Not yet recruiting | ||||
Calgary, Alberta, Canada, T4N 4N2 | |||||
Contact: Bernie Eigl, MD 403-521-3347 bernieei@cancerboard.ab.ca | |||||
Principal Investigator: Bernie Eigl, MD | |||||
Canada, British Columbia | |||||
BC Cancer Agency - Vancouver Centre | Recruiting | ||||
Vancouver, British Columbia, Canada, V5Z 4E6 | |||||
Contact: Kim Chi, MD 604-877-6000 ext 2746 kchi@bccancer.bc.ca | |||||
Principal Investigator: Kim Chi, MD | |||||
Canada, Ontario | |||||
Juravinski Cancer Centre | Not yet recruiting | ||||
Hamilton, Ontario, Canada, L8B 5C2 | |||||
Contact: Sebastien Hotte, MD 905-387-9495 ext 64784 sebastien.hotte@hrcc.on.ca | |||||
Principal Investigator: Sebastien Hotte, MD | |||||
Princess Margaret Hospital | Not yet recruiting | ||||
Toronto, Ontario, Canada, M5G 2M9 | |||||
Contact: Malcolm Moore, MD 416-946-2000 ext 2263 malcolm.moore@uhn.on.ca | |||||
Principal Investigator: Malcolm Moore, MD | |||||
London Health Sciences Centre | Not yet recruiting | ||||
London, Ontario, Canada, N6A 4L6 | |||||
Contact: Eric Winquist, MD 519-685-8640 eric.winquist@lrcc.on.ca | |||||
Principal Investigator: Eric Winquist, MD |
British Columbia Cancer Agency |
Study Chair: | Kim Chi, MD | BC Cancer Agency - Vancouver Centre |
Study ID Numbers: | OZM-005/CEPO906A2402, Protocol number CEP0906A2402, OZM-005 |
First Received: | November 30, 2006 |
Last Updated: | June 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00407251 |
Health Authority: | Canada: Health Canada |
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