Know Cancer

or
forgot password

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate


OBJECTIVES:

- Determine the progression-free and overall survival in patients with high-risk
metastatic adenocarcinoma of the prostate treated with early estramustine, etoposide,
and paclitaxel with combined androgen-blockade therapy.

- Determine the type, frequency, and severity of toxicity of this regimen in this patient
population.

OUTLINE: This is a multicenter study.

- Androgen-blockade therapy: Patients receive a standard regimen of luteinizing
hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously
once monthly or once every 3 months or leuprolide intramuscularly once monthly, once
every 3 months, or once every 4 months. Patients also receive a standard regimen of
antiandrogen therapy comprising oral bicalutamide, oral flutamide, or oral nilutamide
once daily. Treatment continues in the absence of disease progression or unacceptable
toxicity.

- Chemotherapy: Beginning 14-30 days after initiation of androgen-blockade therapy,
patients receive oral estramustine three times daily and oral etoposide once daily on
days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression, every 6 months for 2 years,
and then annually for 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate

- Clinical stage D2 disease as evidenced by one of the following:

- Visceral disease (liver, lung, or other viscera)

- Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull)
and appendicular (claviculae, humeri, or femora) skeleton

- No prior or concurrent (treated or untreated) brain metastases

- Patients with clinical evidence of brain metastasis must have a negative brain
CT or MRI

- No evidence of untreated spinal cord compression

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No active hypercoagulability

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No transient ischemic attacks, stroke, or myocardial infarction within the past 6
months

- No active coronary artery disease requiring antianginal therapy

- No active thrombophlebitis

Pulmonary:

- No history of pulmonary embolus

Other:

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer or adequately treated stage I or II cancer
currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy and recovered

- No concurrent biologic therapy

Chemotherapy:

- No prior cytotoxic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist
and antiandrogen therapy) allowed if administered for a duration of less than 30 days

- Prior neoadjuvant hormonal therapy allowed

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- At least 4 weeks since prior surgery and recovered

Other:

- No concurrent bisphosphonates

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David C. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069132

NCT ID:

NCT00028769

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Puget Sound Oncology ConsortiumSeattle, Washington  98109
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
University of Tennessee Cancer Institute at Methodist Central HospitalMemphis, Tennessee  38104
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Western New York Urology AssociatesBuffalo, New York  14220
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507