NCT00002775

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 I/II trial to study the effectiveness of combining docetaxel and estramustine in treating patients who have metastatic prostate cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 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

February 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

September 2, 2004

Completed
Last Updated

January 6, 2014

Status Verified

April 1, 2000

First QC Date

November 1, 1999

Last Update Submit

January 3, 2014

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancerrecurrent prostate cancer

Interventions

docetaxelDRUG
estramustine phosphate sodiumDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the prostate Failure of androgen ablation (orchiectomy or luteinizing hormone releasing hormone, flutamide) -Rise in PSA greater than 50% of nadir confirmed by 2 measurements 1 week apart -Appearance of new soft tissue lesions -Appearance of new lesions on bone scan Measurable or evaluable disease No symptomatic ascites, pleural effusions, or peripheral edema greater than trace No brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No history of coagulopathy Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT or SGPT no greater than 2.0 times ULN Alkaline phosphatase no greater than 5.0 times ULN Renal: Creatinine no greater than 2.0 times ULN Cardiovascular: No myocardial infarction within past 6 months Pulmonary: No prior pulmonary embolus Neurologic: No prior cerebrovascular accident No symptomatic peripheral neuropathy greater than grade 1 No significant neurologic or psychiatric disorder (psychotic disorder, dementia, or seizure) Other: No other prior malignancy within past 5 years, except: Excised or curatively irradiated nonmelanomatous skin cancer No other serious illness or medical condition No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy At least 6 weeks since prior isotope therapy No prior radiotherapy to greater than 30% of bone marrow Surgery: Not specified 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

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelEstramustine

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 Compounds

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

September 2, 2004

Study Start

February 1, 1998

Last Updated

January 6, 2014

Record last verified: 2000-04

Locations

US(1)