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Androgen-independent Prostate CancerPhase 2NCT00661492

Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)

A Phase 2 study testing cetuximab and Mitoxantrone in people with Androgen-independent Prostate Cancer, run by US Oncology Research at 55 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Androgen-independent Prostate Cancer
What is being tested?
cetuximab and Mitoxantrone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
55 sitesUnited States
Study dates
May 2008to Jun 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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. Note: Patients may have either measurable or non-measurable disease.
  • Radiographic evidence of regional or distant metastases
  • Current evidence of progression (by PSA and/or imaging studies) despite standard hormonal therapy.
  • Progression by PSA will be defined as: A rising PSA defined as: at least 2 rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least 1 week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2. Progression for nonmeasurable disease will be defined as 2 or more new bone lesions; for measurable disease, progression will be defined by standard RECIST criteria.
  • For patients who have been on antiandrogen therapy (ie, bicalutamide, flutamide, etc.), patients must have discontinued anti-androgen therapy for at least 6 weeks (4 weeks for flutamide) without evidence of an antiandrogen withdrawal response. A washout period will not be required for patients who did not respond to an antiandrogen prescribed as second line hormonal therapy. For patients whose progression is documented by PSA, the last required PSA must be after the required anti-androgen washout period (4-6 weeks as appropriate).
  • One prior docetaxel-containing regimen. Patients must have received at least 2 doses in an every 3-week schedule or 6 doses on a weekly schedule of docetaxel. Patients may have discontinued therapy due to progression, intolerance, completion of planned therapy, or other reasons. Chemotherapy treatment with any second-line regimen will not be permitted. Patients who have been previously treated with a first-line docetaxel-based doublet regimen will be eligible for this study, (eg, patients treated on a prior first-line trial containing a docetaxel/carboplatin or other docetaxel-based doublet).
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  • Serum testosterone levels (See protocol for specific details) (unless surgically castrate). Patients must continue androgen deprivation with an LHRH agonist if they have not undergone orchiectomy
  • ECOG performance status
  • Laboratory criteria for entry:
  • absolute neutrophil count
  • platelets
  • bilirubin
  • AST or ALT
  • Life expectancy greater than 3 months
  • Age greater than or equal to 18 years
  • Agree to use contraceptives while on study if sexually active, and for 2 months after the last dose of study drug.
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form

Who cannot join

  • More than 1 prior chemotherapy regimen for metastatic disease
  • Prior history of uncontrolled congestive heart failure or left ventricular ejection fraction (LVEF) that is less than the institution's lower limit of normal on MUGA or echocardiogram
  • A second active malignancy (diagnosed within 5 years) except adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm
  • Significant active concurrent medical illness or infection
  • Treatment with chemotherapy for AIPC within the past 21 days
  • Prior treatment with Novantrone (mitoxantrone)
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  • Prior therapy which specifically and directly targets the EGFR pathway
  • Prior severe infusion reaction to a monoclonal antibody
  • Recent myocardial infarction (within prior 6 months)
  • Prior treatment with radionuclides, with the exception of prior treatment with samarium, which will be allowed provided at least 8 weeks have passed since administration.
  • Is receiving concurrent immunotherapy, hormonal therapy, radiation therapy, or any other non-protocol therapy (excluding LHRH antagonist)
  • Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
  • Has evidence of CNS involvement
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
  • Is unable to comply with requirements of study

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United States55 sites

  • Albany Medical Cancer Center

    Albany, New York, 12208

  • Texas Oncology, P.A. -Amarillo

    Amarillo, Texas, 79106

  • Texas Oncology, P.A.

    Arlington, Texas, 76012

  • Texas Oncology - Central Austin Cancer Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75231

  • Methodist Charlton Cancer Ctr.

    Dallas, Texas, 75237

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Cancer Center

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center-Midtown

    Denver, Colorado, 80218

  • Puget Sound Cancer Center-Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Fairfax Northern VA Hem-Onc PC

    Fairfax, Virginia, 22031

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Texas Oncology, P.A

    Garland, Texas, 75042

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • NH Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46277

  • Columbia Basin Hematology and Oncology

    Kennewick, Washington, 99336

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Longview Cancer Center

    Longview, Texas, 75601

  • South Texas Cancer Center - McAllen

    McAllen, Texas, 78503

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Hematology-Oncology Associates of NNJ, P

    Morristown, New Jersey, 07960

  • Florida Cancer Institute - New Hope

    New Port Richey, Florida, 34655

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • Texas Oncology - Odessa

    Odessa, Texas, 79761

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Interlakes Oncology Hematology, PC

    Rochester, New York, 14623

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Onc and Hem Associates of SW VA, Inc.

    Salem, Virginia, 24153

  • Puget Sound Cancer Center-Seattle

    Seattle, Washington, 98133

  • Northern AZ Hematology & Oncology Assoc

    Sedona, Arizona, 86336

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest-South

    Spokane, Washington, 99202

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Hope Center

    Terre Haute, Indiana, 47802

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Texas Oncology, P.A.

    Webster, Texas, 77598

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-based Chemotherapy

To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment date to the date the patient is first recorded as having disease progression, even in patients who discontinue study treatment early due to toxicity.

Read the detailed description

This is a nonblinded, randomized phase II study to determine the activity of Novantrone (mitoxantrone) with or without Erbitux (cetuximab) in patients with androgen independent prostate cancer (AIPC) who have been treated previously with docetaxel chemotherapy. The Novantrone (mitoxantrone)-only treatment arm will serve as a concurrent control arm to aid in the determination of the benefit of the Novantrone (mitoxantrone)-Erbitux (cetuximab) combination in this setting.

Patients will be randomly assigned 2:1 to 1 of 2 treatment arms; 93 patients in Arm 1 and 47 patients in Arm 2. A balanced randomization procedure will be performed utilizing a code list that will be developed prior to the study opening. Because the patients will be stratified by performance status (ECOG 0 and 1 vs. ECOG 2), the list will be developed to ensure a balance between the 2 treatment arms.

Being tested
cetuximab, Mitoxantrone
Keywords
Androgen-independent prostate cancer(AIPC)

What participants receive

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

  • cetuximabDrug

    Also called Erbitux

    Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter

  • MitoxantroneDrug

    Also called Novantrone

    Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all patients who enter study on LHRH agonists

Study groups in NCT00661492
Study groupRoleWhat they receive
Arm 1ExperimentalErbitux (cetuximab) and Novantrone (mitoxantrone)
Receives: Drug: cetuximab; Drug: Mitoxantrone
Arm 2ExperimentalNovantrone (mitoxantrone)
Receives: Drug: Mitoxantrone

What is being measured

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

  1. Median Time to Progression (TTP)

    TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.

    Measured: 24 months

Secondary outcomes (7)

  1. 2-year Radiographically Evident Progression-free Survival (REPFS).

    Radiographic progression:

    1. For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture).

    Measured: 24 months.

  2. Objective Response Rate (ORR)

    ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    Measured: 24 months

  3. Median Time to Prostate-specific Antigen (PSA) Progression

    Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression.

    Measured: 24 months

  4. Prostate-specific Antigen (PSA) Response Rate

    Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later

    Measured: 24 months

  5. Prostate-specific Antigen (PSA) Doubling Time

    PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)]

    Measured: 24 months

  6. Median Progression-free Survival (PFS)

    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

    Measured: 24 months

  7. Median Overall Survival (OS)

    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    Measured: 30 months

Timeline

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

  1. First posted18 Apr 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2011
  4. Study completionJun 2011

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
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00661492
Sponsor's protocol ID
06-118
Status last verified
Oct 2016
First submitted
4 Apr 2008
Last updated
9 Dec 2016
Data monitoring committee
No

Publications

  • Fleming MT, Sonpavde G, Kolodziej M, Awasthi S, Hutson TE, Martincic D, Rastogi A, Rousey SR, Weinstein RE, Galsky MD, Berry WR, Wang Y, Boehm KA, Asmar L, Rauch MA, Beer TM. Association of rash with outcomes in a randomized phase II trial evaluating cetuximab in combination with mitoxantrone plus prednisone after docetaxel for metastatic castration-resistant prostate cancer. Clin Genitourin Cancer. 2012 Mar;10(1):6-14. doi: 10.1016/j.clgc.2011.11.003.

    PubMed 22340631

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab and Mitoxantrone in people with Androgen-independent Prostate Cancer, run by US Oncology Research at 55 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?

The sponsor lists 18 inclusion and 15 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 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 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?

Yes. Results are posted in the registry (first posted 9 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Time to Progression (TTP) (time frame: 24 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 NCT00661492, 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 9 Dec 2016.

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