NCT00003084

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: Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Dec 1997

Typical duration for phase_2 prostate-cancer

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, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 24, 2004

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

4.9 years

First QC Date

November 1, 1999

Last Update Submit

July 27, 2012

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage II prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancerChemotherapyKetoconazoleEstramustineEtoposidePaclitaxelDoxorubicinVinblastine

Outcome Measures

Primary Outcomes (1)

  • Prostate specific antigen (PSA)- based Response Rate

    8 week cycle

Study Arms (2)

Arm I (Estramustine + Etoposide)

EXPERIMENTAL

Arm I: Oral Estramustine 3 x day + oral Etoposide 2 x day on days 1-14 + Paclitaxel IV over 1 hour Day 2, repeats every 21 days.

Drug: Estramustine phosphate sodiumDrug: EtoposideDrug: Paclitaxel

Arm II (Chemotherapy + Ketoconazole)

EXPERIMENTAL

Arm II: Doxorubicin IV Days 1, 15, and 29, Vinblastine IV Days 8, 22, and 36, Oral Ketoconazole 3 x day on Days 1-7, 15-21, + 29-35, and Oral Estramustine 3 x day on Days 8-14, 22-28, and 36-42; 6 weeks of alternating chemotherapy and 2 weeks rest, for 8 week course.

Drug: Doxorubicin HydrochlorideDrug: Estramustine phosphate sodiumDrug: KetoconazoleDrug: Vinblastine

Interventions

Doxorubicin HydrochlorideDRUG

Doxorubicin IV on days 1, 15, and 29.

Also known as: Adriamycin, Rubex
Arm II (Chemotherapy + Ketoconazole)
Estramustine phosphate sodiumDRUG

Arm I: Oral estramustine three times a day for 21 day cycle. Arm II: Oral estramustine three times a day on days 8-14, 22-28, and 36-42 in 8 week cycle.

Also known as: Emcyt
Arm I (Estramustine + Etoposide)Arm II (Chemotherapy + Ketoconazole)
EtoposideDRUG

Oral etoposide twice daily on days 1-14.

Also known as: VePeside
Arm I (Estramustine + Etoposide)
KetoconazoleDRUG

Oral ketoconazole three times a day on days 1-7, 15-21, and 29-35.

Also known as: Nizoral
Arm II (Chemotherapy + Ketoconazole)
PaclitaxelDRUG

IV over 1 hour on day 2.

Also known as: Taxol
Arm I (Estramustine + Etoposide)
VinblastineDRUG

IV on days 8, 22, and 36.

Also known as: Velban
Arm II (Chemotherapy + Ketoconazole)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Androgen independent disease progression -Castrate testosterone level of less than 40 ng/dL (if medically achieved, treatment must be maintained continuously) -Prostate specific antigen (PSA) at least 4 ng/mL and rising on at least 2 consecutive measurements No variant histologies such as ductal carcinoma (endometrioid or cribiform) or small cell carcinoma Brain metastases controlled PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-3 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.5 g/dL (without transfusion support) Hepatic: Bilirubin and transaminase less than 2 times the upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Estimated creatinine clearance at least 35 mL/min Cardiovascular: No clinical history of heart disease Normal ECG OR Ejection fraction (ECHO, MUGA, or ventriculography) at least 45% Other: Spinal cord compression controlled No active peptic ulcer disease No active, or likely to become active, second malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior ketoconazole Chemotherapy: No prior doxorubicin, vinblastine, estramustine, paclitaxel, or etoposide No greater than one prior cytotoxic therapy No other concurrent chemotherapy At least 8 weeks since prior mitomycin At least 60 days since prior suramin Endocrine therapy: No antiandrogen therapy such as flutamide or nilutamide within 4 weeks (6 weeks for bicalutamide) without response OR Progression since antiandrogen withdrawal Prior dexamethasone therapy discontinued Radiotherapy: At least 10 weeks since prior strontium Sr 89 and no more than 1 prior regimen No concurrent strontium Sr 89 Surgery: Not specified Other: No other concurrent therapy for prostate cancer No concurrent H2 blockers, omeprazole, or antacids No concurrent terfenadine and astemizole

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

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Millikan R, Thall PF, Lee SJ, Jones D, Cannon MW, Kuebler JP, Wade J 3rd, Logothetis CJ. Randomized, multicenter, phase II trial of two multicomponent regimens in androgen-independent prostate cancer. J Clin Oncol. 2003 Mar 1;21(5):878-83. doi: 10.1200/JCO.2003.04.057.

    PMID: 12610188RESULT

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DoxorubicinEstramustineEtoposideKetoconazolePaclitaxelVinblastine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Randall E. Millikan, MD, PhD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 24, 2004

Study Start

December 1, 1997

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)