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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

24 months from study entry

Safety Issue:

No

Principal Investigator

Nancy A. Dawson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000258766

NCT ID:

NCT00052845

Start Date:

November 2002

Completion Date:

April 2009

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Barnes-Jewish HospitalSaint Louis, Missouri  63110
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
Norris Cotton Cancer Center at Dartmouth Medical SchoolLebanon, New Hampshire  03756-0002
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Lombardi Cancer Center of Georgetown University Medical CenterWashington, District of Columbia  20007
Simmons Cancer Center at University of Texas Southwestern Medical Center - DalasDallas, Texas  75235-9154