NCT00005627

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 trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 1999

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

2 active sites

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

March 1, 1999

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

July 18, 2013

Status Verified

April 1, 2003

First QC Date

May 2, 2000

Last Update Submit

July 17, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancer

Interventions

carboplatinDRUG
docetaxelDRUG
estramustine phosphate sodiumDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Disease progression following androgen ablation therapy (hormonal or surgical) by either: * Increase in the product of bidimensional diameters of 1 or more radiographically documented sites of measurable disease OR * Two consecutive increases in PSA documented over a previous reference value * First increase in PSA should occur a minimum of 1 week from the reference value and be confirmed * First PSA value is less than the previous value, then patient is eligible provided next PSA is greater than the second PSA * Testosterone levels documented in the castrate range (i.e., less than 30 ng/mL) PATIENT CHARACTERISTICS: Age: * 18 to 85 Performance status: * CALGB 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR * Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR * SGOT no greater than 1.5 times ULN and alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within past year * No significant change in anginal pattern within past 6 months * No New York Heart Association class II-IV heart disease * No deep venous thrombosis within past year Other: * No significant peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed except taxanes or platinum derivatives Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior antiandrogens Radiotherapy: * At least 4 weeks since prior 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 (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Oh WK, Hagmann E, Manola J, George DJ, Gilligan TD, Jacobson JO, Smith MR, Kaufman DS, Kantoff PW. A phase I study of estramustine, weekly docetaxel, and carboplatin chemotherapy in patients with hormone-refractory prostate cancer. Clin Cancer Res. 2005 Jan 1;11(1):284-9.

    PMID: 15671557RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

CarboplatinDocetaxelEstramustine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • William Oh, MD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

March 1, 1999

Study Completion

April 1, 2003

Last Updated

July 18, 2013

Record last verified: 2003-04

Locations

US(2)