NCT00416533

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

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

August 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
Last Updated

January 19, 2017

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

December 27, 2006

Last Update Submit

January 17, 2017

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage III prostate cancerstage IV prostate canceradenocarcinoma of the prostate

Interventions

docetaxelDRUG
doxorubicin hydrochlorideDRUG
prednisoneDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate with any of the following: * Prostate-specific antigen ≥ 10 mg/dL * Bone disease * Bidimensional soft tissue disease * Evaluable disease * Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal * Disease not amenable to local curative treatment * No known brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine \< 2.0 mg/dL * SGPT and SGOT \< 1.5 times upper limit of normal (ULN) * Bilirubin ≤ ULN * Hemoglobin ≥ 10 g/dL * Ejection fraction ≥ 50% * Peripheral neuropathy ≤ grade 1 * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No previous history of or concurrent malignancy, except for any of the following: * Inactive nonmelanoma skin cancer * Disease-free for five or more years * Adequately treated stage I or II cancer from which patient is currently in complete remission * No other serious medical illness that would limit survival to less than 3 months * No psychiatric condition that would prevent informed consent * No active, uncontrolled bacterial, viral, or fungal infection * No hemorrhagic disorder * No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No new hormonal treatment within the past 4 weeks * No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) * Prior bisphosphonates allowed * At least 2 weeks since prior radiotherapy * No other concurrent chemotherapy

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

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelDoxorubicinPrednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Frank M. Torti, MD, MPH

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

August 1, 2004

Primary Completion

October 1, 2006

Last Updated

January 19, 2017

Record last verified: 2013-06