Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI	CINJ-3850 NCT00176527

Objectives

Primary

1. 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

1. Determine the effect of this regimen on bcl-2 family proteins in peripheral blood mononuclear cell samples obtained from these patients.

Entry 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  • Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease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

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

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

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Robert DiPaola, MD, Principal investigator		Ph: 732-235-7414

Registry Information
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
Trial Start Date		2003-01-01
Registered in ClinicalTrials.gov		NCT00176527
Date Submitted to PDQ		2007-04-25
Information Last Verified		2007-05-01
NCI Grant/Contract Number		CA72720

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