Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]

Prostatic Neoplasms Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268710
• Other study ID #: XRP6976J_2503
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2005
• Last updated: December 4, 2009
• Start date: February 2004
• Est. completion date: March 2006

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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 :

1. Hematology:

• Neutrophils = 1.5 x 10^9/L

• Hemoglobin > 10 g/dL (prior transfusion permitted).

• Platelets = 100 x 10^9/L

2. 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.

3. 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Canadian Urologic Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)		During the Study Conduct	No
Secondary	Analgesics (assessed by Pain Medication Log)		During the study conduct	No
Secondary	PSA (PSA response and PSA progression		During the study conduct	No
Secondary	Tumor lesion assessment,		During the study conduct	No
Secondary	Overall survival		During the study conduct	No
Secondary	Progression-free survival		During the study conduct	No
Secondary	Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.		from the inform consent signed up to the end of the study	No