A fase I/II trial with docetaxel and gemcitabine in hormone refractory prostate cancer

Phase 1

Conditions: Hormone fractory prostate cancer

Registration Number: EUCTR2004-002353-31-DK

Lead Sponsor: Organisation name was not entered

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 60

Inclusion Criteria

Histological documented prostate carcinoma
Hormonrefractary disease
Metastatic disease
PSA>10 microg/l
Progressive rise in PSA in two measurement (>25%)
Castrate level of testosterone
Performance status <=2
No prior treatment with estrogens or prednisolon for prostate cancer
No radionucleid treatment
No concurrent bisphosphonates
No prior systemic chemotherapy
Acceptable liver, hematological and renal function
Signed informed consent
>18 years old

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

Radiotherapy involving more than 25% of bonemarrow area
Other or prior malignant disease except squamous cell skin cancer.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In the phase I part of the study: To establish recommended dosage of docetaxel and gemcitabine for a phase II study in hormone refractory prostate cancer patients.<br>;Secondary Objective: ;Primary end point(s): In the phase II part of the study the primary endpoint is:<br>PSA response<br>and secondary:<br>Toxicity<br>Clinical response of measurable tumor<br>Time to progression<br>Clinical benefit response<br>

Secondary Outcome Measures