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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

  1. First posted27 Jan 2003 (estimated)
  2. Study start5 Apr 2001
  3. Primary completionJul 2004

Resources

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
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.

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.

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