Overview

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.