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Metastatic Prostate CancerPhase 2NCT00599313

Phase II Sunitinib Prog Met AIPC

A Phase 2 study testing Sunitinib in people with Metastatic Prostate Cancer, run by US Oncology Research at 45 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

The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
45 sitesUnited States
Study dates
Mar 2007to Jun 2009
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

  • A patient will be eligible for inclusion in this study if he meets all of the following criteria:
  • Histologically confirmed, adenocarcinoma of the prostate
  • Stage IV(metastatic) disease, documented on CT, MRI, or X-ray
  • Progressive disease (PSA or clinical): PSA progression defined as baseline increase followed by any serial increase after 2 weeks; clinical progression by symptomatic or radiologic criteria.
  • An elevated PSA level of for patients progressing by PSA criteria is required
  • Currently on androgen ablation hormone therapy (an LHRH agonist or orchiectomy) with testosterone level <50ng/dL)
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  • Has received 1 or 2 prior chemotherapy regimens (no more than 2). One prior regimen must be docetaxel.
  • Has an ECOG Performance Status (PS) 0-2
  • Is greater than 18 years of age
  • Meets protocol defined laboratory values
  • Has adequate cardiac function in the opinion of the Investigator
  • Has no uncontrolled arrhythmia or hypertension
  • Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE Version 3.0 Grade less than 1, in the opinion of the Treating Physician
  • If fertile, patient has agreed to use an acceptable method of birth control to prevent pregnancy for the duration of the study and for a period of 2 months thereafter
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form

Who cannot join

  • A patient will be excluded from this study if he meets any of the following criteria:
  • Has any disease other than that described in inclusion criterion #1
  • Had prior treatment with Sutent
  • Has not received prior docetaxel for the current disease
  • Has received any prior radionuclide therapy
  • Has received prior radiation to >50% of the bone marrow
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  • Is receiving concurrent immunotherapy
  • Has a history of hypersensitivity to any of the components of Sutent: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients. The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The caramel gelatin capsule shells also contain yellow iron oxide and black iron oxide. The printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide.
  • Has had significant bleeding in previous 4 weeks
  • Has had any of the following within the prior 6 months: severe/unstable angina, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism
  • Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult
  • Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 4 weeks prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
  • Has uncontrolled arrhythmia or hypertension
  • Has evidence of uncontrolled CNS involvement (previous radiation and off steroids is acceptable)
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
  • Is unable to comply with requirements of study

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • Texas Cancer Center-Abilene(South)

    Abilene, Texas, 79606

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Texas Oncology, P.A.-Amarillo

    Amarillo, Texas, 79106

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology, P.A.-Bedford

    Bedford, Texas, 76022

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Onclogy, 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

  • Puget Sound Cancer Center-Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • NH Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Allison Cancer Center

    Midland, Texas, 79701

  • Cancer Care & Hematology Specialista of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Texas Oncology-Odessa

    Odessa, Texas, 79761

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • 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

  • HOAST-Medical Dr.

    San Antonio, Texas, 78229

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Puget Sound Cancer Center-Seattle

    Seattle, Washington, 98133

  • Arch Medical Services, Inc. DBA The Cntr for Cancer Care & Research

    St Louis, Missouri, 63141

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Hope Center

    Terre Haute, Indiana, 47802

  • Connecticut Oncology & Hematology, LLP

    Torrington, Connecticut, 06790

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care and Research

    Waco, Texas, 76712

  • Texas Oncology, P.A.

    Webster, Texas, 77598

  • Alliance Hematology Oncology PA

    Westminster, Maryland, 21157

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-based Chemotherapy

The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.

Read the detailed description

The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC.

Being tested
Sunitinib
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • SunitinibDrug

    Also called Sunitinib malate, Sutent

    50 mg/day orally each of Days 1-28 of each 6 week cycle

Study groups in NCT00599313
Study groupRoleWhat they receive
Sunitinib MalateExperimentalSunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Receives: Drug: Sunitinib

What is being measured

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

  1. Median Progression-free Survival (PFS) Time at 1-year.

    PFS is measured from the date of registration 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.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: 12 months

Secondary outcomes (5)

  1. Overal Survival (OS) Rate at 1-year.

    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: 12 months

  2. Prostate Specific Antigen (PSA) Response

    Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.

    Measured: Baseline and up to 12 months

  3. Change of PSA Doubling Time

    Difference of PSA doubling time between baseline and end of the treatment.

    Measured: Baseline and up to 12 months

  4. Objective Response Rate (ORR)

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

    Measured: 12 months

  5. Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.

    Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week's average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week's period.

    Measured: Baseline and up to 12 months

Timeline

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

  1. First posted23 Jan 2008 (estimated)
  2. Study startMar 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00599313
Sponsor's protocol ID
05112
Other IDs
2006-0012
Status last verified
Sep 2018
First submitted
11 Jan 2008
Last updated
25 Oct 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Metastatic Prostate Cancer, run by US Oncology Research at 45 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 16 inclusion and 18 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 8 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 Progression-free Survival (PFS) Time at 1-year. (time frame: 12 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 NCT00599313.

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 25 Oct 2018.

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