Phase II Sunitinib Prog Met AIPC

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Prostate Cancer
• Intervention / Treatment: Drug: Sunitinib

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Hematology Oncology Associates
  • Connecticut
    • Torrington, Connecticut, United States, 06790
      • Connecticut Oncology & Hematology, LLP
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
  • Illinois
    • Niles, Illinois, United States, 60714
      • Cancer Care & Hematology Specialista of Chicagoland
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Hope Center
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology, P.A.
    • Westminster, Maryland, United States, 21157
      • Alliance Hematology Oncology PA
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Missouri Cancer Associates
    • Saint Joseph, Missouri, United States, 64507
      • St. Joseph Oncology, Inc.
    • Saint Louis, Missouri, United States, 63141
      • Arch Medical Services, Inc. DBA The Cntr for Cancer Care & Research
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Hampshire
    • Hooksett, New Hampshire, United States, 03106
      • NH Oncology-Hematology PA
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • New Mexico Cancer Care Associates
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, P.C.
    • Rochester, New York, United States, 14623
      • Interlakes Oncology Hematology, PC
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Cancer Centers of North Carolina
  • Ohio
    • Kettering, Ohio, United States, 45409
      • Greater Dayton Cancer Center
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Medical Oncology Associates
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Cancer Centers of the Carolinas
  • Texas
    • Abilene, Texas, United States, 79606
      • Texas Cancer Center-Abilene(South)
    • Amarillo, Texas, United States, 79106
      • Texas Oncology, P.A.-Amarillo
    • Arlington, Texas, United States, 76014
      • Texas Cancer Center
    • Austin, Texas, United States, 78731
      • Texas Oncology Cancer Center
    • Beaumont, Texas, United States, 77702
      • Mamie McFaddin Ward Cancer Center
    • Bedford, Texas, United States, 76022
      • Texas Oncology, P.A.-Bedford
    • Dallas, Texas, United States, 75246
      • Texas Oncology, P.A.
    • Dallas, Texas, United States, 75230
      • Texas Cancer Center at Medical City
    • Dallas, Texas, United States, 75237
      • Methodist Charlton Cancer Ctr.
    • Dallas, Texas, United States, 75231
      • Texas Onclogy, P.A.
    • Denton, Texas, United States, 76210
      • Texas Cancer Center
    • El Paso, Texas, United States, 79915
      • El Paso Cancer Treatment Ctr
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology, P.A.
    • Midland, Texas, United States, 79701
      • Allison Cancer Center
    • Odessa, Texas, United States, 79761
      • Texas Oncology-Odessa
    • Paris, Texas, United States, 75460
      • Paris Regional Cancer Center
    • San Antonio, Texas, United States, 78229
      • HOAST-Medical Dr.
    • Sugar Land, Texas, United States, 77479
      • Texas Oncology Cancer Center-Sugar Land
    • Waco, Texas, United States, 76712
      • Texas Oncology Cancer Care and Research
    • Webster, Texas, United States, 77598
      • Texas Oncology, P.A.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Salem, Virginia, United States, 24153
      • Onc and Hem Associates of SW VA, Inc.
  • Washington
    • Edmonds, Washington, United States, 98026
      • Puget Sound Cancer Center-Edmonds
    • Seattle, Washington, United States, 98133
      • Puget Sound Cancer Center-Seattle
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists-Vancouver
    • Yakima, Washington, United States, 98902
      • Yakima Valley Mem Hosp/North Star Lodge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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)
• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunitinib Malate; Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)	Drug: Sunitinib; 50 mg/day orally each of Days 1-28 of each 6 week cycle; Other Names: Sutent; Sunitinib malate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Prostate Specific Antigen (PSA) Response	Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.	Baseline and up to 12 months
Change of PSA Doubling Time	Difference of PSA doubling time between baseline and end of the treatment.	Baseline and up to 12 months
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.	12 months
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.	Baseline and up to 12 months

Collaborators and Investigators

• Sponsor: US Oncology Research
• Collaborators: Pfizer
• Investigators: Principal Investigator: Guru Sonpavde, MD, US Oncology Research

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (Estimate): January 23, 2008

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: 05112; 2006-0012 (Other Identifier: Pfizer)