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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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- Patients who have been recently withdrawn from treatment with bicalutamide or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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (biochemical and measurable disease)

Safety Issue:

No

Principal Investigator

Robert S. DiPaola, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Institutional Review Board

Study ID:

CDR0000540176

NCT ID:

NCT00176527

Start Date:

November 2002

Completion Date:

August 2007

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Cancer Institute of New JerseyNew Brunswick, New Jersey  08901