NCT00006114

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

10 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

March 1, 2011

Status Verified

September 1, 2000

First QC Date

August 3, 2000

Last Update Submit

February 26, 2011

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancerrecurrent prostate cancer

Interventions

mitoxantrone hydrochlorideDRUG
vinorelbine tartrateDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate * Progressive disease despite hormonal therapy or orchiectomy * No brain metastases PATIENT CHARACTERISTICS: Age: * 18 to 80 Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 9 g/dL Hepatic: * Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (unless bone metastasis) * Bilirubin less than 2 times ULN Renal: * Creatinine less than 2 times ULN Cardiovascular: * Adequate cardiac function Other: * No other prior malignancy except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * See Disease Characteristics * Prior corticosteroids allowed if started at least 8 weeks prior to study Radiotherapy: * At least 8 weeks since prior extensive radiotherapy Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (10)

Hopital Saint-Louis

Amiens, 80054 Cedex 1, France

Location

Hopital Gouin

Clichy, 92110, France

Location

Hopital Perpetuel Secours

Levallois-Perret, 92300, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Hopital Laennec

Paris, 75007, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

Toulon, 83056, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

MitoxantroneVinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Jean-Louis Wendling, MD

    Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

May 1, 1999

Last Updated

March 1, 2011

Record last verified: 2000-09

Locations

FR(10)