NCT00176527

Brief Summary

RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Nov 2002

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 11, 2009

Status Verified

December 1, 2009

Enrollment Period

4.8 years

First QC Date

September 12, 2005

Last Update Submit

December 10, 2009

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Response (biochemical and measurable disease)

  • Bcl-2 modulation in peripheral blood mononuclear cells

Interventions

recombinant interferon alfa-2bBIOLOGICAL
docetaxelDRUG
estramustine phosphate sodiumDRUG
isotretinoinDRUG
polyacrylamide gel electrophoresisGENETIC
protein expression analysisGENETIC
immunohistochemistry staining methodOTHER

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed hormone-refractory metastatic prostate cancer * Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease * Measurable disease OR prostate-specific antigen level ≥ 10 ng/mL PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Estimated life expectancy ≥ 6 months * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 8 g/dL * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min * Bilirubin normal * AST, ALT, and alkaline phosphatase (AP) must meet 1 of the following criteria: * AP normal and AST and ALT ≤ 2.5 times upper limit of normal (ULN) * AP elevated and AST and ALT normal * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No peripheral neuropathy \> grade 1 * No concurrent active infections * No concurrent major depression or suicidal ideation * No concurrent medical condition that would preclude study participation * No known HIV positivity * Fertile patients must use effective contraception during and for 10 weeks after completion of study therapy PRIOR CONCURRENT THERAPY: * Recovered from prior surgery or radiotherapy * No prior chemotherapy, retinoids, or interferon therapy * More than 4 weeks since prior flutamide * More than 6 weeks since prior bicalutamide

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

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

IntronsDocetaxelEstramustineIsotretinoinElectrophoresis, Polyacrylamide GelImmunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesPigments, BiologicalBiological FactorsElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Robert S. DiPaola, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2002

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

December 11, 2009

Record last verified: 2009-12

Locations

US(1)