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Prostate CancerPhase 2NCT00052845

Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase 2 study testing docetaxel, estramustine phosphate sodium and exisulind in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 80 sites in 3 countries.

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. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
docetaxel, estramustine phosphate sodium and exisulind
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
80 sitesin 3 countries
Study dates
Nov 2002to Apr 2009
Phase
Phase 2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Progressive systemic (metastatic) disease despite castrate levels of testosterone secondary to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy
  • Castrate levels of testosterone must be maintained
  • LHRH analog therapy should be continued
  • Failed prior standard androgen-deprivation therapy
  • Serum testosterone no greater than 50 ng/mL for patients who have not had bilateral orchiectomy
  • Evidence of metastatic disease on CT scan, MRI, or bone scan (no positron-emission tomography or prostascint)
  • Evidence of progressive disease after most recent prior therapy (including hormonal therapy) as defined by 1 of the following:
  • Measurable disease progression
  • More than 20% increase in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of 1 or more new lesions
  • Bone scan progression
  • Appearance of 1 or more new lesions on bone scan attributable to prostate cancer AND
  • PSA at least 5 ng/mL
  • PSA progression
  • PSA at least 5 ng/mL which has increased serially from baseline on 2 occasions (at least 1 week apart) NOTE: If the confirmatory PSA is less than screening PSA, an additional test for rising PSA is required

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • AST and ALT no greater than 1.5 times upper limit of normal (ULN)
  • Bilirubin no greater than ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No myocardial infarction within the past year
  • No significant change in anginal pattern within the past year
  • No congestive heart failure
  • No New York Heart Association class II-IV heart disease
  • No deep vein thrombosis within the past year

Pulmonary

  • No pulmonary embolus within the past year

Other

  • No clinically significant peripheral neuropathy
  • No known hypersensitivity to sulindac
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic chemotherapy (including estramustine or suramin)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide and megestrol
  • At least 6 weeks since prior bicalutamide and nilutamide
  • At least 4 weeks since prior hormonal therapy known to decrease PSA levels (including ketoconazole, aminoglutethimide, finasteride, or any systemic corticosteroid)
  • Concurrent primary testicular androgen suppression therapy (e.g., with a LHRH analog) allowed
  • No other concurrent hormonal therapy except:
  • Steroids for adrenal insufficiency
  • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • Intermittent dexamethasone as an antiemetic

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
  • No concurrent palliative radiotherapy

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered

Other

  • At least 4 weeks since prior herbal product known to decrease PSA levels (including saw palmetto, PC-SPES)
  • More than 1 week since prior sulindac
  • No concurrent sulindac
  • No concurrent chronic nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors and salicylates such as aspirin, mesalamine, salsalate, and sulfasalazine)
  • Concurrent ibuprofen and naproxen allowed
  • Low-dose aspirin (e.g., 81 mg/day) for cardiovascular prevention allowed
  • No concurrent full-dose oral or parenteral anticoagulation therapy
  • Concurrent bisphosphonate therapy allowed provided therapy was initiated at least 4 weeks before study and disease has progressed despite therapy

Trial locations and contacts

80 sites in 3 countries.

80 sites in 3 countries

United States78 sites

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36207

  • Veterans Affairs Medical Center - Asheville

    Asheville, North Carolina, 28805

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland, 21201

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22902

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • NorthEast Oncology Associates

    Concord, North Carolina, 28025

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75216

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas

    Dallas, Texas, 75235-9154

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Veterans Affairs Medical Center - Fargo

    Fargo, North Dakota, 58102

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28302-2000

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana, 46885-5099

  • Memorial Regional Hospital Comprehensive Cancer Center

    Hollywood, Florida, 33021

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Lenoir Memorial Hospital Cancer Center

    Kinston, North Carolina, 28503-1678

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Veterans Affairs Medical Center - Las Vegas

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth Medical School

    Lebanon, New Hampshire, 03756-0002

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

    Los Angeles, California, 90048

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • Ministry Medical Group - Northern Region

    Rhinelander, Wisconsin, 54501

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • West Suburban Center for Cancer Care

    River Forest, Illinois, 60305

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Lakeland Medical Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • Lombardi Cancer Center of Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Veterans Affairs Medical Center - Washington, DC

    Washington D.C., District of Columbia, 20422

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28402-9025

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

Canada1 site

  • McGill University

    Montreal, Quebec, H2W 1S6

Other trials in Canada

Puerto Rico1 site

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, Puerto Rico, 00936-5067

Other trials in Puerto Rico

About this study

Official title: A Phase II Study Of Estramustine, Docetaxel, And Exisulind (IND #64733) In Men With Hormone Refractory Prostate Cancer

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining these therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Read the detailed description

OBJECTIVES:

  • Determine the time to objective and biochemical progression and response proportion (objective and post-therapy changes in PSA) in patients with hormone refractory metastatic prostate cancer treated with docetaxel, estramustine, and exisulind.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5, docetaxel IV over 1 hour on day 2, and oral exisulind twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years.

Conditions
Prostate Cancer
Being tested
docetaxel, estramustine phosphate sodium, exisulind
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV 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

    70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle

  • estramustine phosphate sodiumDrug

    280 mg PO tid Days 1-5 of ea cycle

  • exisulindDrug

    Two 125 mg capsules PO bid Days 1-21 of ea cycle

Study groups in NCT00052845
Study groupRoleWhat they receive
Combined chemotherapyExperimentalcombination of 3 chemotherapy agents for hormone refractory prostate cancer
Receives: Drug: docetaxel; Drug: estramustine phosphate sodium; Drug: exisulind

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression

    Measured: 24 months from study entry

Secondary outcomes (3)

  1. Toxicity

    Measured: treatment up to 3 mon post treatment

  2. Changes in PSA

    Measured: During treatment then q 3 mon until ds progression

  3. Overall Survival

    Measured: 24 months from study entry

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 startNov 2002
  3. Primary completionJan 2006
  4. Study completionApr 2009

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052845
Sponsor's protocol ID
CALGB-90004
Other IDs
U10CA031946, CALGB-90004, CDR0000258766
Status last verified
Jun 2016
First submitted
24 Jan 2003
Last updated
1 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Dawson NA, Halabi S, Ou SS, Biggs DD, Kessinger A, Vogelzang N, Clamon GH, Nanus DM, Kelly WK, Small EJ; Cancer And Leukemia Group B. A phase II study of estramustine, docetaxel, and exisulind in patients with hormone- refractory prostate cancer: results of cancer and leukemia group B trial 90004. Clin Genitourin Cancer. 2008 Sep;6(2):110-6. doi: 10.3816/CGC.2008.n.017.

    PubMed 18824434

  • Dawson NA, Halabi S, Biggs DD, et al.: A phase II study of estramustine (E), docetaxel (D) and exisulind in hormone-refractory prostate cancer (HRPC): toxicity results of CALGB 90004. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-289, 2005.

  • Dawson NA, Halabi S, Biggs DD, et al.: A phase II Study of estramustine (E), docetaxel (D) and exisulind in hormone-refractory prostate cancer (HRPC): initial results of CALGB 90004 . [Abstract] J Clin Oncol 23 (Suppl 16): A-4649, 415s, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel, estramustine phosphate sodium and exisulind in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 80 sites in 3 countries.

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 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Canada, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Time to progression (time frame: 24 months from study entry). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00052845, which also lists 3 linked publications.

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 1 Jul 2016.

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