Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic Cancer

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborator: Sanofi
• Treatments: Docetaxel; Estramustine; Hormones; Prednisone

Criteria

Inclusion Criteria:

• Signed informed consent prior to beginning protocol specific procedures.

• 18 years

• Histologically/cytologically proven prostate adenocarcinoma.

• Documented metastatic prostate adenocarcinoma

• Patients must have received prior hormonal therapy as defined below:

• Castration by orchiectomy and/or LHRH agonists with or without

• Antiandrogens

• Other hormonal agents (e.g., ketoconazole, ...)

• Testosterone level should be < 50 ng/dl in all patients (castrated level).

• Respect of antiandrogen withdrawal period

• No prior chemotherapy regimen at the exception of estramustine phosphate.

• documented disease progression defined either (i) by PSA increase and/or (ii) imaging:

• Prior radiation therapy (to less or equal than 25% of the bone marrow only) is allowed. At least 4 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects.

• Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery.

• Life expectancy > 3 months.

• ECOG performance status 0-2.

• Normal cardiac function.

Exclusion Criteria:

• Prior chemotherapy except estramustine phosphate.(2)

• Prior isotope therapy

• Prior radiotherapy to >25% of bone marrow

• Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.

• Known brain or leptomeningeal involvement.

• Symptomatic peripheral neuropathy > grade 2

• Other serious illness or medical condition

• Concurrent treatment with other experimental drugs.

• Treatment with any other anti-cancer therapy (except LHRH agonists)

• Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped prior to the administration of docetaxel.