Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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This is a prospective phase II trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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docetaxel and samarium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years and less than 80 years
* Histologically-proven adenocarcinoma of the prostate
* Evidence of bone metastases and progressive, hormone-refractory, disease
* No previous chemotherapy
* No previous radiotherapy, except radiotherapy directed to the prostate and/or to a single bony lesion
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent.

Exclusion Criteria

* Patients infected by the Human Immunodeficiency Virus (HIV)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Karim Fizazi, Dr

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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TAX-SAMAR

Identifier Type: -

Identifier Source: org_study_id