Status:
COMPLETED
Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Canadian Urologic Oncology Group
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
Primary objectives: * To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting. Secondary objectives: * To evaluate the overall safety and toxicity of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically/cytologically proven prostate adenocarcinoma
- Progression or non response with previous chemotherapy regimen (excluding Taxotere®)
- Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine
- Castration levels of testosterone (\<50 ng/dL )
- ECOG performance status 0-2
- Laboratory requirements :
- Hematology:
- Neutrophils ≥ 1.5 x 10\^9/L
- Hemoglobin \> 10 g/dL (prior transfusion permitted).
- Platelets ≥ 100 x 10\^9/L
- Hepatic function:
- Total bilirubin \< the upper-normal limit of the institution.
- ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the institution.
- Renal function:
- Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)
- No severe or uncontrolled disease
- Exclusion Criteria
- Chemotherapy within the last 4 weeks
- Anti-androgen therapy within the last 4 weeks.
- Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for \>2 years.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry.
- Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00268710
Start Date
February 1 2004
End Date
March 1 2006
Last Update
December 7 2009
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