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Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176527
Recruitment Status : Terminated (accrual goal met)
First Posted : September 15, 2005
Last Update Posted : December 11, 2009
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey

Brief Summary:

RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells.

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: recombinant interferon alfa-2b Drug: docetaxel Drug: estramustine phosphate sodium Drug: isotretinoin Genetic: polyacrylamide gel electrophoresis Genetic: protein expression analysis Other: immunohistochemistry staining method Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (R.I.T.E.) for the Treatment of Hormone Refractory Prostate Cancer
Study Start Date : November 2002
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Response (biochemical and measurable disease)
  2. Bcl-2 modulation in peripheral blood mononuclear cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176527

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United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
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Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
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Responsible Party: Robert DiPaola, MD, UMDNJ/CINJ Identifier: NCT00176527    
Other Study ID Numbers: CDR0000540176
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2009
Keywords provided by Rutgers, The State University of New Jersey:
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Interferon alpha-2
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal