NCT00003633

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: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced prostate cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

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

August 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 19, 2013

Status Verified

March 1, 2005

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancerrecurrent prostate cancer

Interventions

docetaxelDRUG
estramustine phosphate sodiumDRUG
mitoxantrone hydrochlorideDRUG
prednisoneDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria: * Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart * Appearance of new lesions on bone scan * Appearance of new soft-tissue lesions * Measurable or evaluable disease * No brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Greater than 3 months Hematopoietic: * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * SGOT and SGPT no greater than 2 times ULN Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * No history of coagulopathy * No myocardial infarction in the last 6 months * No history of cardiovascular accident * No history of congestive heart failure Neurological: * No symptomatic peripheral neuropathy greater than grade 1 * No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures Pulmonary: * No history of pulmonary embolus Other: * Testosterone no greater than 3.5 nmol/L * No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease * No active infection * No other serious illness or medical condition * No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists) Radiotherapy: * No prior radiotherapy to greater than 30% of bone marrow * At least 6 weeks since isotope therapy * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * At least 4 weeks since prior investigational drugs

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

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelEstramustineMitoxantronePrednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticQuinonesPregnadienediolsPregnadienesPregnanes

Study Officials

  • Daniel P. Petrylak, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

August 1, 1998

Last Updated

December 19, 2013

Record last verified: 2005-03

Locations

US(1)