Prostate CancerPhase 2NCT00005847
Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase 2 study testing recombinant interferon alfa, estramustine phosphate sodium and isotretinoin in people with Prostate Cancer, run by Eastern Cooperative Oncology Group at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- recombinant interferon alfa, estramustine phosphate sodium and isotretinoin
- How many people
- Not given
- Where
- 19 sitesUnited States
- Study dates
- 5 Apr 2001to Jul 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Tufts - New England Medical Center
Boston, Massachusetts, 02111
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226-3596
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, 10466
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- recombinant interferon alfa, estramustine phosphate sodium, isotretinoin, mitoxantrone hydrochloride, paclitaxel
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
estramustine phosphate sodiumDrug
isotretinoinDrug
mitoxantrone hydrochlorideDrug
paclitaxelDrug
vinorelbine ditartrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start5 Apr 2001
- Primary completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert S. DiPaola, MD, Study chair, Rutgers Cancer Institute of New JerseyRobert G. Kilbourn, MD, PhD, Study chair, Texas Oncology, PA - San Marcos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005847
- Sponsor's protocol ID
- CDR0000067865
- Other IDs
- E-3899
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2000
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005847
- Acronym / sponsor ID
- CDR0000067865
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Apr 2001 (actual)
- Primary completion
- Jul 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| estramustine phosphate sodium | Drug | – |
| isotretinoin | Drug | – |
| mitoxantrone hydrochloride | Drug | – |
| paclitaxel | Drug | – |
| vinorelbine ditartrate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publicationDipaola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S. DiPaola, MD study chair
Rutgers Cancer Institute of New Jersey
Robert G. Kilbourn, MD, PhD study chair
Texas Oncology, PA - San Marcos
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa, estramustine phosphate sodium and isotretinoin in people with Prostate Cancer, run by Eastern Cooperative Oncology Group at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.