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Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00115635
Recruitment Status : Completed
First Posted : June 24, 2005
Last Update Posted : October 2, 2007
Eli Lilly and Company
Information provided by:
Herlev Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Drug: gemcitabine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
Study Start Date : March 2005
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Clinical response
  2. Time to PSA progression
  3. Toxicity

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00115635     History of Changes
Other Study ID Numbers: UR0416
EudraCT number: 2004-002353-31
First Posted: June 24, 2005    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: October 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