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

May 13, 2011 updated by: Groupe D'Etude des Tumeurs Uro-Genitales

Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14076
        • Centre Regional Francois Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic progressive disease meeting the following criteria:

      • Increase in measurable lesions > 25%
      • Increase in bone lesions > 25%
      • Biological progression rate of PSA > 4 ng/mL
  • Received docetaxel as first-line chemotherapy
  • Received at least 1 prior regimen of hormone therapy
  • Pain > 2 on Visual Analog Scale or continuing level 2 analgesics
  • No symptomatic or evolutionary CNS disease

PATIENT CHARACTERISTICS:

  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times normal
  • Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
  • Transaminases ≤ 1.5 times normal
  • Bilirubin ≤ 1.5 times normal
  • No prior malignancy except basal cell skin cancer
  • No peripheral neuropathy or severe neuropathy ≥ grade 2
  • No other severe lung, hepatic, renal, or digestive disease that would be complicated by treatment
  • LVEF > 50%
  • No history of peptic ulcer, unstable diabetes, or other contraindication to using steroids
  • No severe infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 8 weeks since prior metabolic radiotherapy
  • More than 4 weeks since prior external radiotherapy
  • At least 1 month since prior docetaxel-based chemotherapy
  • At least 1 month since prior antiandrogen therapy in the case of complete hormonal blockage
  • No participation in another clinical trial within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Palliative response rate

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe D'Etude des Tumeurs Uro-Genitales

Investigators

  • Study Chair: Florence Joly, MD, PhD, Centre François Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574184
  • GETUG- P02
  • INCA-RECF0422
  • EUDRACT-2006-001597-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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