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A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer


OBJECTIVES:

- Compare time to objective progression in patients with prostate cancer and a rising
prostate-specific antigen (PSA) after androgen suppression when treated with
second-line hormonal therapy (ketoconazole and hydrocortisone) vs combination
chemotherapy (docetaxel and estramustine).

- Compare time to PSA progression and correlate this with time to objective progression
in patients treated with these regimens.

- Compare the quality of life in patients treated with these regimens.

- Compare overall survival of patients treated with these regimens.

- Compare the natural history of progression in patients treated with these regimens.

- Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of
apoptopic biomarkers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
treatment with bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive oral ketoconazole three times daily and oral hydrocortisone
twice daily. Treatment continues in the absence of disease progression or unacceptable
toxicity.

- Arm II: Patients receive oral estramustine three times daily on days 1-5 and docetaxel
IV over 1 hour on day 2. Treatment repeats every 3 weeks for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of week 9, at 6 months and 1 year, and
then annually for up to 10 years or until beginning of first non-protocol therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this
study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate that was continuously treated
with androgen suppression

- Rising prostate-specific antigen (PSA), defined as PSA > 5 ng/mL, rising on 2
consecutive measurements at least 4 weeks apart

- Gleason score 7 or higher and/or seminal vesicle involvement at diagnosis

- Patients previously treated with antiandrogen or glucocorticoid therapy must meet the
following criteria:

- Must show a continued rise in PSA after stopping antiandrogen (flutamide,
bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)

- At least 4 weeks continued rise in PSA after flutamide or nilutamide (6
weeks for bicalutamide)

- Testosterone less than 50 ng/dL

- Patients who have not undergone surgical castration must continue primary
androgen suppression to maintain castrate levels of testosterone

- No progressive or measurable local or metastatic disease (including bone metastases)

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 2,000/mm^3

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

Hepatic:

- SGOT no greater than 2 times upper limit of normal

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine no greater than 1.7 mg/dL

Cardiovascular:

- No American Heart Association class III or IV heart disease

- No uncontrolled congestive heart failure

- No life-threatening cardiac arrhythmias

Other:

- Fertile patients must use effective contraception

- No other prior malignancy unless curatively treated and disease-free for appropriate
time period for specific cancer

- No preexisting peripheral neuropathy greater than grade 1

- No known hypersensitivity to polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 5 years since prior systemic chemotherapy

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since prior hydrocortisone

- No prior ketoconazole

Radiotherapy:

- At least 28 days since prior radiotherapy to primary site

- No prior palliative radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- Recovered form prior therapy

- At least 7 days since prior parenteral antibiotics for active infection

- No concurrent digitalis

- No concurrent H_2 blockers or proton pump inhibitors (arm I only)

- Concurrent bisphosphonates allowed provided they were initiated prior to study
therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael A. Carducci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069088

NCT ID:

NCT00027859

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Harrington Cancer CenterAmarillo, Texas  79106
Martha Jefferson HospitalCharlottesville, Virginia  22901
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
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
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
St. Mary's Medical CenterHuntington, West Virginia  25701
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Mount Sinai Medical CenterNew York, New York  10029
Comprehensive Cancer InstituteHuntsville, Alabama  35801
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Memorial Regional Cancer Center at Memorial Regional HospitalHollywood, Florida  33021
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Medical Center of Aurora - South CampusAurora, Colorado  80012-0000
Rocky Mountain Cancer Centers - Denver RoseDenver, Colorado  80220
Rocky Mountain Cancer Centers - ThorntonThornton, Colorado  80229