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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
estramustine phosphate sodium
isotretinoin
mitoxantrone hydrochloride
paclitaxel
vinorelbine ditartrate
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • CCOP - Colorado Cancer Research Program, Incorporated
  • Emory University Hospital - Atlanta
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • CCOP - Carle Cancer Center
  • Tufts - New England Medical Center
  • CCOP - Kalamazoo
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey
  • MBCCOP-Our Lady of Mercy Cancer Center
  • CCOP - Merit Care Hospital
  • Ireland Cancer Center
  • CCOP - Toledo Community Hospital
  • CCOP - Geisinger Clinic and Medical Center
  • Fox Chase Cancer Center
  • CCOP - Sioux Community Cancer Consortium
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Medical College of Wisconsin Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005847
Brief Title
Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2001 (Actual)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
estramustine phosphate sodium
Intervention Type
Drug
Intervention Name(s)
isotretinoin
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
vinorelbine ditartrate

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. DiPaola, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert G. Kilbourn, MD, PhD
Organizational Affiliation
Texas Oncology, PA - San Marcos
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
MBCCOP-Our Lady of Mercy Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

Learn more about this trial

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

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