Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
NCT ID: NCT00176527
Last Updated: 2009-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2002-11-30
2007-08-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Detailed Description
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Primary
* Determine the response rate, in terms of change in measurable disease or prostate-specific antigen levels, in patients with hormone-refractory metastatic prostate cancer treated with isotretinoin, recombinant interferon alfa-2b, docetaxel, and estramustine phosphate sodium.
Secondary
* Determine the effect of this regimen on bcl-2 family proteins in peripheral blood mononuclear cell samples obtained from these patients.
OUTLINE: Patients receive oral isotretinoin once daily on days 1-4, recombinant interferon alfa-2b subcutaneously once daily on days 1-4, oral estramustine phosphate sodium three times daily on days 1-5, and docetaxel IV over 1 hour on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2, 3, or 4 and analyzed for bcl-2 protein by IHC and electrophoresis.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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recombinant interferon alfa-2b
docetaxel
estramustine phosphate sodium
isotretinoin
polyacrylamide gel electrophoresis
protein expression analysis
immunohistochemistry staining method
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed hormone-refractory metastatic prostate cancer
* Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease
* Measurable disease OR prostate-specific antigen level ≥ 10 ng/mL
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Estimated life expectancy ≥ 6 months
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin ≥ 8 g/dL
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
* Bilirubin normal
* AST, ALT, and alkaline phosphatase (AP) must meet 1 of the following criteria:
* AP normal and AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* AP elevated and AST and ALT normal
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No peripheral neuropathy \> grade 1
* No concurrent active infections
* No concurrent major depression or suicidal ideation
* No concurrent medical condition that would preclude study participation
* No known HIV positivity
* Fertile patients must use effective contraception during and for 10 weeks after completion of study therapy
PRIOR CONCURRENT THERAPY:
* Recovered from prior surgery or radiotherapy
* No prior chemotherapy, retinoids, or interferon therapy
* More than 4 weeks since prior flutamide
* More than 6 weeks since prior bicalutamide
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Medicine and Dentistry of New Jersey
OTHER
Responsible Party
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UMDNJ/CINJ
Principal Investigators
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Robert S. DiPaola, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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CINJ#080107-3850
Identifier Type: -
Identifier Source: secondary_id
CDR0000540176
Identifier Type: -
Identifier Source: org_study_id