NCT00627354

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 16, 2011

Status Verified

July 1, 2009

Enrollment Period

4.7 years

First QC Date

February 29, 2008

Last Update Submit

May 13, 2011

Conditions

Prostate Cancer

Keywords

stage IV prostate cancerrecurrent prostate canceradenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

  • Palliative response rate

Secondary Outcomes (8)

  • Duration of palliative response

  • Biological response

  • Tumor response as assessed by RECIST criteria

  • Time to progression

  • Overall survival

  • +3 more secondary outcomes

Interventions

etoposideDRUG
mitoxantrone hydrochlorideDRUG
prednisoneDRUG
vinorelbine tartrateDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Regional Francois Baclesse

Caen, 14076, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

EtoposideMitoxantronePrednisoneVinorelbine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesAnthraquinonesAnthronesAnthracenesQuinonesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Florence Joly, MD, PhD

    Centre Francois Baclesse

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 3, 2008

Study Start

September 1, 2006

Primary Completion

May 1, 2011

Last Updated

May 16, 2011

Record last verified: 2009-07

Locations

FR(1)