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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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa-2b
docetaxel
estramustine phosphate sodium
isotretinoin
polyacrylamide gel electrophoresis
protein expression analysis
immunohistochemistry staining method
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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CHARACTERISTICS: Histologically confirmed hormone-refractory metastatic prostate cancer Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease Measurable disease OR prostate-specific antigen level ≥ 10 ng/mL PATIENT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

Sites / Locations

  • Cancer Institute of New Jersey

Outcomes

Primary Outcome Measures

Response (biochemical and measurable disease)
Bcl-2 modulation in peripheral blood mononuclear cells

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
December 10, 2009
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00176527
Brief Title
Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
accrual goal met
Study Start Date
November 2002 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
estramustine phosphate sodium
Intervention Type
Drug
Intervention Name(s)
isotretinoin
Intervention Type
Genetic
Intervention Name(s)
polyacrylamide gel electrophoresis
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Primary Outcome Measure Information:
Title
Response (biochemical and measurable disease)
Title
Bcl-2 modulation in peripheral blood mononuclear cells

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. DiPaola, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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