Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Eli Lilly and Company
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00115635
First received: June 23, 2005
Last updated: October 1, 2007
Last verified: October 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115635

Locations
Denmark
Dept. of Oncology, 54B1, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Sanofi
Eli Lilly and Company
Investigators
Principal Investigator: Lisa Sengelov, MD Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark
  More Information

No publications provided

ClinicalTrials.gov 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
Health Authority: Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 20, 2014