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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
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00176527
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: estramustine phosphate sodium
Drug: isotretinoin
Drug: recombinant interferon alfa-2b
Procedure: immunohistochemistry staining method
Procedure: polyacrylamide gel electrophoresis
Procedure: protein expression analysis
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Docetaxel Isotretinoin Tretinoin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Estramustine Estramustine phosphate Estramustine phosphate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response (biochemical and measurable disease) [ Designated as safety issue: No ]
  • Bcl-2 modulation in peripheral blood mononuclear cells [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2003
Detailed Description:

OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176527

Locations
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Cancer Institute of New Jersey
Investigators
Principal Investigator: Robert S. DiPaola, MD Cancer Institute of New Jersey
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000540176, CINJ-3850
Study First Received: September 12, 2005
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00176527  
Health Authority: United States: Institutional Review Board

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Genital Neoplasms, Male
Prostatic Diseases
Interferons
Estramustine
Urogenital Neoplasms
Genital Diseases, Male
Recurrence
Docetaxel
Isotretinoin
Tretinoin
Interferon Alfa-2a
Prostatic Neoplasms
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Angiogenesis Modulating Agents
Growth Inhibitors
Dermatologic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009