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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176527
• Other study ID #: CDR0000540176
• Secondary ID: P30CA072720CINJ#
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 10, 2009
• Start date: November 2002
• Est. completion date: August 2007

Study information

• Verified date: December 2009
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• recombinant interferon alfa-2b

Drug:
• docetaxel

• estramustine phosphate sodium

• isotretinoin

Genetic:
• polyacrylamide gel electrophoresis

• protein expression analysis

Other:
• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response (biochemical and measurable disease)			No
Primary	Bcl-2 modulation in peripheral blood mononuclear cells			No