NCT00020046

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel with or without thalidomide in treating patients who have metastatic prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

December 1, 1999

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
Last Updated

October 31, 2023

Status Verified

March 1, 2012

First QC Date

March 2, 2007

Last Update Submit

October 27, 2023

Conditions

Stage IV Prostate CancerAdenocarcinoma of the ProstateRecurrent Prostate Cancer

Keywords

adenocarcinoma of the prostateadult solid tumorbody system/site cancercancercellular diagnosis, prostate cancergenetic conditionmale reproductive cancerprostate cancerrecurrent prostate cancersolid tumorstage IV prostate cancerstage, prostate cancer

Interventions

docetaxelDRUG
thalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed androgen-independent metastatic adenocarcinoma of the prostate Clinically progressive disease documented by at least 1 of the following: Two consecutively rising PSA levels (PSA at least 5.0) At least 1 new lesion on bone scan Progressive measurable disease If no prior surgical castration, serum testosterone must be less than 50 ng/mL and continue on gonadotropin-releasing hormone If receiving an antiandrogen and PSA level rising, must demonstrate a continued rise in PSA 4 weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide No brain metastases --Prior/Concurrent Therapy-- Biologic therapy: No prior thalidomide Chemotherapy: No prior chemotherapy for metastatic prostate cancer No prior docetaxel Endocrine therapy: See Disease Characteristics Radiotherapy: Recovered from prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.0 mg/dL AST/ALT less than 2.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No history of myocardial infarction within past 6 months No uncontrolled congestive heart failure or angina pectoris Other: No other prior active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder Fertile patients must use effective contraception at least 1 month prior to, during, and for 1 month after study

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

Sponsors & Collaborators

Study Sites (1)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Sissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24.

    PMID: 21106711DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasmsGenetic Diseases, Inborn

Interventions

DocetaxelThalidomide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • William Dahut

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 5, 2007

Study Start

December 1, 1999

Study Completion

September 1, 2003

Last Updated

October 31, 2023

Record last verified: 2012-03

Locations

US(1)