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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2005

Last Updated Date

October 1, 2007

Start Date ^ICMJE

March 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Prostate-specific antigen (PSA) response

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00115635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical response
Time to PSA progression
Toxicity

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: docetaxel
Drug: gemcitabine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00115635

Other Study ID Numbers ^ICMJE

UR0416, EudraCT number: 2004-002353-31

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Herlev Hospital

Collaborators ^ICMJE

Sanofi
Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Lisa Sengelov, MD

Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark

Information Provided By

Herlev Hospital

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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