Status:
TERMINATED
Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy given as a primary treatment to patients with early and rapid PSA rising after prostatectomy for high risk dise...
Detailed Description
Patients with high-risk prostate cancer have a high probability of PSA failure after radical prostatectomy. However, more than half of these patients will remain free of PSA recurrence for more than 1...
Eligibility Criteria
Inclusion
- Diagnosis of prostate adenocarcinoma on a radical prostatectomy.
- Prior radical prostatectomy within less than 2 years from the time of first PSA rise.
- Demonstration of biochemical recurrence based on a PSA detectable \>0.03 less than 24 months after radical prostatectomy and confirmed on 2 additional tests.
- PSA doubling time over three values must be \<= 9 months for PSA \>=0.4 and PSA \<=10. If PSA is \>10, there is no need for PSA doubling time.
- Karnofsky performance status (KPS) \>=70%
- Adequate organ function as defined by hemogram with haemoglobin \>8.0, platelet \>100 000, white blood cell \>3,500, creatinine clearance \>=60 cc/min and normal liver function tests.
- Neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that the total duration of therapy did not exceed 6 months.
- Subjects must have signed an informed consent document stating that they understand the investigational or nature of the proposed treatment.
- Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion
- Clinical significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- Uncontrolled serious active infection.
- Anticipated duration of life less than 2 years.
- Less than 5-year history of successful treatment for other cancers or concurrent active non prostate cancer other than non melanoma dermatologic tumors and non-muscle invasive bladder tumors.
- Peripheral neuropathy \>=2 grade 2
- Concurrent experimental treatment or involvement in other clinical trials involving drugs.
- Other severe acute or chronic medical conditions including psychiatric diseases or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety.
- Subjects who participated in another clinical study/received investigational product within 30 days of screening for this study.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00714376
Start Date
May 1 2008
End Date
July 1 2008
Last Update
October 31 2012
Active Locations (1)
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1
Centre de recherche clinique et evaluative en oncologie, L'Hôtel-Dieu de Québec-CHUQ
Québec, Quebec, Canada