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

This study has been terminated.
(accrual goal met)
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176527
First received: September 12, 2005
Last updated: December 10, 2009
Last verified: December 2009
  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
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

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

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: November 2002
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Robert DiPaola, MD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00176527     History of Changes
Other Study ID Numbers: CDR0000540176, P30CA072720, CINJ#080107-3850
Study First Received: September 12, 2005
Last Updated: December 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Docetaxel
Estramustine
Isotretinoin
Sodium phosphate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on April 16, 2014