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Prostate CancerPhase 3NCT00027859

Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

A Phase 3 study testing docetaxel, estramustine phosphate sodium and ketoconazole in people with Prostate Cancer, run by Eastern Cooperative Oncology Group at 98 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
docetaxel, estramustine phosphate sodium and ketoconazole
How many people
Not given
Where
98 sitesUnited States
Study dates
8 Oct 2003to Dec 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

98 sites in 1 country.

98 sites in 1 country

United States98 sites

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • Medical Center of Aurora - South Campus

    Aurora, Colorado, 80012-0000

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22902

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428-1002

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • St. Joseph Hospital

    Denver, Colorado, 80218-1191

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers - Denver Rose

    Denver, Colorado, 80220

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Swedish Medical Center

    Englewood, Colorado, 80112

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28302-2000

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54307-3453

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Memorial Regional Cancer Center at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Veterans Affairs Medical Center - Little Rock

    Little Rock, Arkansas, 72205

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-0001

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226-3596

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6307

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615-7828

  • Abramson Cancer Center at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • St. Mary-Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • West Suburban Center for Cancer Care

    River Forest, Illinois, 60305

  • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke

    Roanoke, Virginia, 24014

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101-4295

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Rocky Mountain Cancer Centers - Thornton

    Thornton, Colorado, 80221

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

Other trials in United States

About this study

Official title: 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

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
docetaxel, estramustine phosphate sodium, ketoconazole, therapeutic hydrocortisone
Keywords
adenocarcinoma of the prostate, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxelDrug

  • estramustine phosphate sodiumDrug

  • ketoconazoleDrug

  • therapeutic hydrocortisoneDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start8 Oct 2003
  3. Primary completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00027859
Sponsor's protocol ID
CDR0000069088
Other IDs
E1899, SWOG-E1899, CALGB-E1899
Status last verified
Jun 2023
First submitted
7 Dec 2001
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Walczak JR, Carducci MA; Eastern Cooperative Oncology Group E1899. Phase 3 randomized trial evaluating second-line hormonal therapy versus docetaxel-estramustine combination chemotherapy on progression-free survival in asymptomatic patients with a rising prostate-specific antigen level after hormonal therapy for prostate cancer: an Eastern Cooperative Oncology Group (E1899), Intergroup/Clinical Trials Support Unit study. Urology. 2003 Dec 29;62 Suppl 1:141-6. doi: 10.1016/j.urology.2003.09.006.

    PubMed 14747052

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing docetaxel, estramustine phosphate sodium and ketoconazole in people with Prostate Cancer, run by Eastern Cooperative Oncology Group at 98 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00027859, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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