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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 Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Barnes-Jewish Hospital Saint Louis, Missouri  63110
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Green Mountain Oncology Group Rutland, Vermont  05701
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Martha Jefferson Hospital Charlottesville, Virginia  22901
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Saint Anthony Medical Center Rockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Baltimore Baltimore, Maryland  21201
Lakeland Medical Center - St. Joseph Saint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
NorthEast Oncology Associates Concord, North Carolina  28025
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Ministry Medical Group - Northern Region Rhinelander, Wisconsin  54501
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
Norris Cotton Cancer Center at Dartmouth Medical School Lebanon, New Hampshire  03756-0002
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Lombardi Cancer Center of Georgetown University Medical Center Washington, District of Columbia  20007
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas Dallas, Texas  75235-9154