Status:
COMPLETED
Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Sanofi
Eli Lilly and Company
Conditions:
Prostate Cancer
Eligibility:
MALE
18-95 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to effica...
Eligibility Criteria
Inclusion
- Histologically verified adenocarcinoma of the prostate.
- Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
- Stage IV disease (verified by imaging or clinical examination).
- PSA \> 10 microgram/l.
- PSA progression defined as a \> 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
- Castrate level of testosterone (\< 50 ng).
- No previous oestrogen or steroid as metastatic prostate cancer treatment.
- Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
- Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
- Satisfactory haematologic function defined as ANC \>1.5 x 10\^9/l, leucocytes \>3.0 x 10\^9/l, thrombocytes ≥ 100 x 10\^9/l, haemoglobin \> 7 mmol/l
- ECOG performance status ≤ 2.
- Life expectancy \> 3 months.
- Patient must be able to adhere to protocol requirements.
- Written informed consent.
- \> 18 years of age.
Exclusion
- Previous prostate cancer treatment with oestrogens or steroid hormones.
- Previous chemotherapy.
- Previous treatment with systemic radioactive isotopes.
- Bisphosphonate treatment (concomitant).
- Radiation therapy covering more than 25% of the bone marrow producing area.
- Other serious coincidental and/or concomitant medical condition.
- Symptomatic cerebral metastases.
- Other previous or current malignant disease, excluding \*adequately treated and cured planocellular skin carcinoma; or \*other cancer assessed to carry minimal risk of recurrence.
- ECOG performance status \> 2.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00115635
Start Date
March 1 2005
End Date
July 1 2007
Last Update
October 2 2007
Active Locations (1)
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1
Dept. of Oncology, 54B1, Herlev Hospital
Herlev, Denmark, 2730