Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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ClinicalTrials.gov Identifier: NCT00005847 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: January 27, 2010
|
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known which treatment regimen is more effective in treating metastatic prostate cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with that of chemotherapy plus biological therapy in treating patients who have progressive or metastatic prostate cancer that has not responded to hormone therapy.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Biological: recombinant interferon alfa Drug: estramustine phosphate sodium Drug: isotretinoin Drug: mitoxantrone hydrochloride Drug: paclitaxel Drug: vinorelbine ditartrate | Phase 2 |
OBJECTIVES:
- Compare the effect of estramustine, mitoxantrone, and vinorelbine vs isotretinoin, interferon alfa, and paclitaxel on PSA response in patients with metastatic hormone-refractory prostate cancer.
- Determine the toxic effects of each regimen in this patient population.
- Determine the effect of each regimen on pain, fatigue, and quality of life in these patients.
- Determine the objective response rate among the subset of patients who have bidimensionally measurable disease to each regimen after treatment.
- Determine the effect of each regimen on peripheral blood mononuclear cell BCL-2 in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease (measurable vs nonmeasurable and elevated PSA). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive vinorelbine IV over 10 minutes on days 2 and 9 followed by mitoxantrone IV over 10 minutes on day 2 only. Oral estramustine is administered every 12 hours on days 1-5. Courses repeat every 3 weeks in the absence of unacceptable toxicity, disease progression, or administration of the maximum cumulative dose of mitoxantrone.
- Arm II: Patients receive oral isotretinoin and interferon alfa subcutaneously on days 1 and 2 and paclitaxel IV over 1 hour on day 2 weekly for 6 weeks. Courses repeat every 8 weeks in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, on day 2 of courses 2, 4, and 6 (arm I), on day 22 of course 1 and day 1 of courses 2 and 3 (arm II), and then at completion of treatment.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 70-114 patients (35-57 per arm) will be accrued for this study within 14-23 months.
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Trial of Mitoxantrone, Estramustine and Navelbine or 13-cis Retinoic Acid, Interferon and Paclitaxel in Patients With Metatstatic Hormone Refractory Prostate Cancer |
Study Start Date : | January 2001 |
Actual Primary Completion Date : | July 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
-
Evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases)
- Radiologic evidence of hydronephrosis only does not constitute evidence of metastatic disease
- Must not have an elevated serum alkaline phosphatase or PSA level as only evidence of disease
- If bone metastases only (i.e., lacking soft tissue disease), must have PSA level of at least 20 ng/mL
- If soft tissue metastases and/or visceral disease, must have either bidimensionally measurable disease or PSA level of at least 20 ng/mL
- Must have had prior bilateral orchiectomy or other primary hormonal therapy (e.g., estrogen therapy or LHRH blocker plus flutamide) with evidence of treatment failure
- No carcinomatous meningitis or brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Granulocyte count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- See Disease Characteristics
- Bilirubin no greater than 1.5 mg/dL
- SGOT/SGPT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No active angina pectoris
- No New York Heart Association class III or IV heart disease
- No myocardial infarction within the past 6 months
- No deep venous thrombosis
- LVEF at least 50% by MUGA
Other:
- Fertile patients must use effective contraception during and for 1 month after study
- Prior malignancy allowed provided curatively treated and disease free for appropriate time period for specific cancer
- No other serious medical illness or active infection that would preclude protocol therapy
- No concurrent prolonged exposure to sunlight
- No concurrent alcohol consumption
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy, including neoadjuvant chemotherapy or single-agent estramustine
Endocrine therapy:
- See Disease Characteristics
- If no prior bilateral orchiectomy, must continue LHRH agonist therapy (e.g., depot leuprolide or goserelin)
- At least 4 weeks since prior flutamide or flutamide with evidence of progressive disease
- At least 6 weeks since prior bicalutamide with evidence of progressive disease
Radiotherapy:
- More than 4 weeks since prior radiotherapy
- No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other radioisotope therapies
Surgery:
- See Disease Characteristics
Other:
- Recovered from all toxic effects due to prior treatment for prostate cancer
- No concurrent milk, milk products, antacids, calcium-containing drugs, or any food with estramustine (arm I only)
- No concurrent vitamin supplements containing vitamin A (arm II only)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005847
United States, Colorado | |
CCOP - Colorado Cancer Research Program, Incorporated | |
Denver, Colorado, United States, 80224 | |
United States, Georgia | |
Emory University Hospital - Atlanta | |
Atlanta, Georgia, United States, 30322 | |
Veterans Affairs Medical Center - Atlanta (Decatur) | |
Decatur, Georgia, United States, 30033 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
United States, Massachusetts | |
Tufts - New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Michigan | |
CCOP - Kalamazoo | |
Kalamazoo, Michigan, United States, 49007-3731 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
United States, New Jersey | |
CCOP - Northern New Jersey | |
Hackensack, New Jersey, United States, 07601 | |
Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
MBCCOP-Our Lady of Mercy Cancer Center | |
Bronx, New York, United States, 10466 | |
United States, North Dakota | |
CCOP - Merit Care Hospital | |
Fargo, North Dakota, United States, 58122 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
CCOP - Toledo Community Hospital | |
Toledo, Ohio, United States, 43623-3456 | |
United States, Pennsylvania | |
CCOP - Geisinger Clinic and Medical Center | |
Danville, Pennsylvania, United States, 17822-2001 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, South Dakota | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57104 | |
United States, Wisconsin | |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
Green Bay, Wisconsin, United States, 54307-3453 | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226-3596 |
Study Chair: | Robert S. DiPaola, MD | Rutgers Cancer Institute of New Jersey | |
Study Chair: | Robert G. Kilbourn, MD, PhD | Texas Oncology, PA - San Marcos |
Publications of Results:
Responsible Party: | Group Chair, Eastern Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00005847 History of Changes |
Other Study ID Numbers: |
CDR0000067865 E-3899 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | January 27, 2010 |
Last Verified: | January 2010 |
Keywords provided by Eastern Cooperative Oncology Group:
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Paclitaxel Vinorelbine Vinblastine Albumin-Bound Paclitaxel Interferons Mitoxantrone Estramustine Hormones |
Interferon-alpha Isotretinoin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents Immunologic Factors Analgesics Sensory System Agents |