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Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

This study has been completed.
Eli Lilly and Company
Information provided by:
Herlev Hospital Identifier:
First received: June 23, 2005
Last updated: October 1, 2007
Last verified: October 2007
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.

Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response

Secondary Outcome Measures:
  • Clinical response
  • Time to PSA progression
  • Toxicity

Enrollment: 60
Study Start Date: March 2005
Study Completion Date: July 2007

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00115635

Dept. of Oncology, 54B1, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Eli Lilly and Company
Principal Investigator: Lisa Sengelov, MD Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark
  More Information Identifier: NCT00115635     History of Changes
Other Study ID Numbers: UR0416
EudraCT number: 2004-002353-31
Study First Received: June 23, 2005
Last Updated: October 1, 2007

Keywords provided by Herlev Hospital:
Hormonal refractory, chemotherapy, docetaxel, gemcitabine

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on April 26, 2017