Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00627354
• Lead Sponsor: Groupe D'Etude des Tumeurs Uro-Genitales

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.

PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Detailed Description

OBJECTIVES:

Primary

* Determine the palliative response rate in patients with hormone-resistant prostate cancer treated with mitoxantrone hydrochloride vs etoposide vs vinorelbine ditartrate as second-line therapy.

Secondary

* Determine the duration of palliative response in patients treated with these regimens.

* Determine the biological response (PSA \> 50%) in these patients.

* Determine the time to progression (biological and clinical) in these patients.

* Determine the overall survival of these patients.

* Determine the quality of life and the impact on autonomy of patients over 70 years of age.

* Determine the toxicity of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive mitoxantrone hydrochloride IV over 5 minutes once a week for 3 weeks.

* Arm II: Patients receive oral etoposide twice daily on days 1-14.

* Arm III: Patients receive oral vinorelbine ditartrate once daily on days 1 and 8 and oral prednisone once daily on days 1-21.

Treatment in all three arms repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Status Verified: 2009-07
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Palliative response rate

Secondary Outcome Measures

Name	Time	Method
Duration of palliative response
Biological response
Tumor response as assessed by RECIST criteria
Time to progression
Overall survival
Quality of life as assessed by QLQ-PR25
Impact on autonomy in patients > 70 years of age
Toxicity

Trial Locations

Locations (1)

Centre Regional Francois Baclesse; 🇫🇷 Caen, France