Clinical trial NCT00115635: Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
Official title: A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Hormonal refractory, chemotherapy, docetaxel, gemcitabine
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Eli Lilly and Company
First posted: 2005-06-24
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 efficacy and toxicity in a phase II trial.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Prostate-specific antigen (PSA) response
Secondary outcomes:
measure: Clinical response
measure: Time to PSA progression
measure: Toxicity
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Dept. of Oncology, 54B1, Herlev Hospital
Study officials:
affiliation: Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark
name: Lisa Sengelov, MD
role: PRINCIPAL_INVESTIGATOR
References: