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Adenocarcinoma of the ProstatePhase 2NCT00058084

Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer

A Phase 2 study testing ixabepilone, mitoxantrone hydrochloride and prednisone in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site 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

This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
ixabepilone, mitoxantrone hydrochloride and prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Mar 2003to 1 Oct 2007
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease (positive bone scan or measurable disease)
  • Progressive hormone-refractory disease
  • Based on 1 of the following:
  • Transaxial imaging
  • Rise in prostate-specific antigen (PSA)
Show all 61Show fewer
  • Radionuclide bone scan
  • Must have undergone primary hormonal treatment (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without an antiandrogen) and demonstrated disease progression after antiandrogen discontinuation as defined below:
  • Two consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression
  • For patients receiving flutamide, at least 1 PSA value must be obtained at least 4 weeks after flutamide discontinuation
  • For patients receiving bicalutamide or nilutamide, at least 1 PSA value must be obtained at least 6 weeks after antiandrogen discontinuation
  • Ineligible if sole manifestation of progression is an increase in disease-related symptoms
  • Meets 1 of the following criteria:
  • Measurable disease and an elevated PSA
  • Nonmeasurable disease and an elevated PSA, as follows:
  • Positive bone scan
  • PSA level at least 5 ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
  • New metastatic lesions by radionuclide bone scan
  • Must have received at least 2 courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or no more than 60 days after cessation of therapy*
  • Testosterone < 50 ng/dL
  • No known active brain metastases
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 3 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 40 mL/min
  • Ejection fraction ≥ lower limit of normal by MUGA or echocardiogram
  • No myocardial infarction within the past 6 months
  • No significant cardiovascular disease
  • No New York Heart Association class III or IV congestive heart failure
  • No active angina pectoris
  • Fertile patients must use effective contraception before, during, and for 3 months after study therapy
  • No prior hypersensitivity reaction to agents containing Cremophor®EL
  • No serious infection
  • No nonmalignant medical illnesses that are uncontrolled or whose control would be jeopardized by complications of study therapy
  • No psychiatric illness or social situation that would preclude study compliance
  • No motor or sensory neuropathy grade 2 or greater
  • No "currently active" second malignancy except nonmelanoma skin cancer
  • Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered to have less than a 30% risk of relapse
  • No concurrent prophylactic colony-stimulating factors for myelosuppression
  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen
  • No prior mitoxantrone or epothilone
  • No other concurrent chemotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior antiandrogens (e.g., flutamide) (6 weeks for bicalutamide or nilutamide)
  • Patients must continue primary androgen deprivation therapy with luteinizing hormone-releasing hormone agonist during study if prior orchiectomy was not performed
  • At least 4 weeks since prior systemic (including oral) corticosteroids except corticosteroids as part of first-line chemotherapy tapered off over 10-14 days prior to study entry
  • At least 4 weeks since any prior hormonal therapy, including megestrol or finasteride
  • No other concurrent systemic steroids
  • At least 4 weeks since prior radiotherapy
  • More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
  • No concurrent radiotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., Saw Palmetto or PC-SPES)
  • More than 4 weeks since other prior antiprostate cancer therapy
  • More than 4 weeks since prior systemic therapies for prostate cancer
  • No other concurrent investigational agents

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143-0875

Other trials in United States

About this study

Official title: A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer

This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the efficacy of ixabepilone (BMS-247550) vs mitoxantrone and prednisone, in terms of decline in prostate-specific antigen (PSA) levels, in patients with taxane-resistant, hormone-refractory metastatic prostate cancer.

SECONDARY OBJECTIVES:

  1. Determine the safety of these regimens in these patients. II. Determine the objective response rate in patients with measurable disease who are treated with these regimens.

III. Determine the clinical activity of each of these regimens after crossover in patients who experience disease progression on their originally assigned treatment arm and switch to the other treatment arm.

OUTLINE: This is a randomized, crossover, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1 or 2). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.

ARM II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21.In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients who progress while on treatment after at least 2 courses or discontinue treatment for any other reason may cross over to the other arm and receive treatment as above, beginning within 12 weeks of last study treatment on original arm.

Patients are followed every 3 months.

Being tested
ixabepilone, mitoxantrone hydrochloride, prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ixabepiloneDrug

    Also called BMS-247550, epothilone B lactam, Ixempra

    Given IV

  • mitoxantrone hydrochlorideDrug

    Also called CL 232315, DHAD, DHAQ, Novantrone

    Given IV

  • prednisoneDrug

    Also called DeCortin, Deltra

    Given orally

Study groups in NCT00058084
Study groupRoleWhat they receive
Arm IExperimentalPatients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.
Receives: Drug: ixabepilone
Arm IIExperimentalPatients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: mitoxantrone hydrochloride; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to the randomized treatment as determined by > 50% PSA response as measured by RECIST criteria

    The frequency of response with 95% confidence limits for a binomial outcome will be calculated.

    Measured: Up to 3 months

Secondary outcomes (4)

  1. Frequency of any toxicity by grade

    Measured: Up to 3 months

  2. Response duration

    Will be estimated using the Kaplan-Meier product limit method.

    Measured: From the date PR or CR is first determined until the first evidence of progressive disease, assessed up to 3 months

  3. Time to progressive disease

    Will be estimated using the Kaplan-Meier product limit method.

    Measured: From the date protocol therapy is started until the first evidence of progressive disease, assessed up to 3 months

  4. Frequency of response to third-line (crossover) therapy

    Estimates of response to third line treatment along with 95% confidence intervals will be calculated.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2003 (estimated)
  2. Study startMar 2003
  3. Primary completion1 Oct 2007

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058084
Sponsor's protocol ID
NCI-2012-02526
Other IDs
UCSF-02555, N01CM62206, CDR0000285731
Status last verified
Feb 2017
First submitted
7 Apr 2003
Last updated
23 Feb 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone, mitoxantrone hydrochloride and prednisone in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site 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?

The sponsor lists 61 inclusion and 0 exclusion criteria. 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does the primary outcome measure?

Response to the randomized treatment as determined by > 50% PSA response as measured by RECIST criteria (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058084.

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 23 Feb 2017.

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