NCT Number: NCT00268710
Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]
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 Taxotere®/prednisone combination as second line therapy in HRPC * To evaluate PSA response (PSA: Prostate Specific Antigen) * To evaluate symptomatic response * To evaluate Quality of life * To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)
Time frame: During the Study Conduct
Secondary outcomes
-
Analgesics (assessed by Pain Medication Log)
Time frame: During the study conduct
-
PSA (PSA response and PSA progression
Time frame: During the study conduct
-
Tumor lesion assessment,
Time frame: During the study conduct
-
Overall survival
Time frame: During the study conduct
-
Progression-free survival
Time frame: During the study conduct
-
Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.
Time frame: from the inform consent signed up to the end of the study
Sponsors and collaborators
Lead sponsor
Sanofi
Industry
Collaborators
- Canadian Urologic Oncology Group
Registry information
Official study title
Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC)
Important dates
- Study start
- 2004
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Dec 22, 2005
- Registry last updated
- Dec 7, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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