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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
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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


- 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


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Granulocyte count at least 1,500/mm^3

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


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

- Bilirubin no greater than ULN


- Creatinine no greater than 1.5 times ULN


- 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


- No pulmonary embolus within the past year


- No clinically significant peripheral neuropathy

- No known hypersensitivity to sulindac

- Fertile patients must use effective contraception


Biologic therapy

- Not specified


- 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)

- 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


- At least 4 weeks since prior radiotherapy and recovered

- At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam

- No concurrent palliative radiotherapy


- See Disease Characteristics

- At least 4 weeks since prior major surgery and recovered


- 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:


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:


Principal Investigator

Nancy A. Dawson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Food and Drug Administration

Study ID:




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



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