Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115635
• Other study ID #: UR0416
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 23, 2005
• Last updated: October 1, 2007
• Start date: March 2005
• Est. completion date: July 2007

Study information

• Verified date: October 2007
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel

• gemcitabine

Locations

Country	Name	City	State
Denmark	Dept. of Oncology, 54B1, Herlev Hospital	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Herlev Hospital	Eli Lilly and Company, Sanofi

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate-specific antigen (PSA) response
Secondary	Clinical response
Secondary	Time to PSA progression
Secondary	Toxicity