A PHASE II TRIAL TO ASSESS THE EFFICACY OF EFAVIRENZ IN METASTATIC PATIENTS WITH ANDROGEN-INDEPENDENT PROSTATE CANCER - FAVE

• Conditions: Male patients aged 18 and over with castration-refractory metastatic prostate cancer histologically confirmed with WHO performance status ranged from 0 to 2, and without any clinical symptom related to disease progression.; MedDRA version: 9.1Level: LLTClassification code 10036947Term: Prostatic cancer metastatic

• Registration Number: EUCTR2008-002730-30-FR
• Lead Sponsor: Institut Bergonié - Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-ouest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Provision of written informed consent prior any study-related procedures.
2.Male aged 18 years and over.
3.Previously confirmed histological diagnosis of prostate adenocarcinoma.
4.Evidence of metastases (including bone, lymph nodes, or other site), radiologically or histologically documented.
5.Despite a serum testosterone level inferior or equal to 50 ng/dL proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in PSA that meets all the following criteria:
a.3 consecutive dosages of PSA, each of them showing an increase of the PSA value compared to the previous dosage (if the third PSA value is lower than the second PSA value, a fourth PSA assessment is required and the PSA value should be higher than the second PSA value)
b.2 weeks minimum time interval between sampling
c.All PSA values must be equal or higher than 5 ng/mL and should have been assessed in the same laboratory using the same PSA assay
6.Word Health Organisation (WHO) performance status ranged from 0 to 2 (see Appendix 1).
7.No prior cytotoxic chemotherapy for the treatment of prostate cancer.
8.No clinical symptom related to disease progression: no bone pain related to bone metastasis, no change in the urinary symptoms during the last 6 months.
9.Treated with luteinising hormone-releasing hormone (LHRH) analogue and peripheral antiandrogens for 6 months at least and confirmation of the initial tumoral response at the start of this treatment. Continued elevation of the PSA can be demonstrated during the washout times provided above.
10.Withdrawal of antiandrogens, at least 6 weeks before inclusion in the study. LH-RH analogue should be maintained.
11.Biphosphonate therapy is allowed if the first dose was administered more than 30 days before inclusion.
12.Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.No metastatic prostate cancer or no resistance to castration or symptomatic prostate cancer.
2.Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral orchiectomy within the 30 days preceding inclusion visit. Incompletely healed surgical incision.
3.Concomitant anticancer therapy other than surgical castration or continuous medical castration.
4.Previous treatment with chemotherapy including taxans or estracyt®.
5.Biology:
a.Neutrophils < 1.5 × 109/L or platelets < 100 × 109/L
b.Serum creatinine > 1.5 × the upper limit of reference range (ULRR) or creatinine clearance = 60 mL/ minute (calculated by the Cockcroft-Gault formula)
c.Potassium < 4.0 mmol/L despite supplementation; serum calcium (ionized calcium level or adjusted for albumin) or magnesium below the normal range despite supplementation
d.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULRR; alkaline phosphatase (ALP) > 2.5 × ULRR, or > 5 × ULRR if judged by investigator to be related to liver metastasis; serum bilirubine > 1.5 × ULRR.
6.Human Immunodeficiency Virus (HIV) positive.
7.In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. currently unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
8.Previous or current malignancies other than prostate cancer within the last 5 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin.
9.Known hypersensitivity to study treatment and to their excipients.
10.Severe hepatic impairment.
11.Concomitant treatment with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, rye alkaloids, voriconazole, herbal extract from St. John's wort (Hypericum perforatum).
12.Depressive status (with a score = 13 on the HAD scale).
13.Any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy.
14.Currently active diarrhoea that may affect the ability of the patient to absorb the study treatment.
15.Previous exposure or any previous treatment acting on signal transduction pathway.
16.Participation in a clinical study and / or receipt of an investigational drug during the last 30 days.
17.Previous enrolment in the present study.
18.Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified