Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00005847 | Completed Phase 2

• 2 other identifiers: CDR0000067865E-3899
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Interventions

recombinant interferon alfa BIOLOGICAL

estramustine phosphate sodium DRUG

isotretinoin DRUG

mitoxantrone hydrochloride DRUG

paclitaxel DRUG

vinorelbine ditartrate DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (19)

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Related Publications (1)

• Dipaola RS, Manola J, Li S, et al.: A randomized phase II trial of mitoxantrone, estramustine and vinorelbine or 13-cis retinoic acid, interferon and paclitaxel in patients with metastatic hormone refractory prostate cancer: results of ECOG 3899. [Abstract] J Clin Oncol 22 (Suppl 14): A-4594, 405s, 2004.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interferon-alpha; Estramustine; Isotretinoin; Mitoxantrone; Paclitaxel; Vinorelbine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Quinones; Taxoids; Cyclodecanes; Diterpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Robert S. DiPaola, MD

  Rutgers Cancer Institute of New Jersey

  STUDY CHAIR

• Robert G. Kilbourn, MD, PhD

  Texas Oncology, PA - San Marcos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: April 5, 2001
• Primary Completion: July 1, 2004
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (19)