Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

October 1, 2007 updated by: Herlev Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Dept. of Oncology, 54B1, Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prostate-specific antigen (PSA) response

Secondary Outcome Measures

Outcome Measure
Toxicity
Clinical response
Time to PSA progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

Eli Lilly and Company
Sanofi

Investigators

  • Principal Investigator: Lisa Sengelov, MD, Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

June 23, 2005

First Submitted That Met QC Criteria

June 23, 2005

First Posted (Estimate)

June 24, 2005

Study Record Updates

Last Update Posted (Estimate)

October 2, 2007

Last Update Submitted That Met QC Criteria

October 1, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UR0416
  • EudraCT number: 2004-002353-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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