Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
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 |
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| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| Principal Investigator: | Robert S. DiPaola, MD | 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 University of Medicine and Dentistry 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 June 18, 2013