Phase II Sunitinib Prog Met AIPC

NCT00599313 | Completed Phase 2 Results

• 2 other identifiers: 051122006-0012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 45

Brief Summary

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

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (5)

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

  12 months

• Prostate Specific Antigen (PSA) Response

  Baseline and up to 12 months

• Change of PSA Doubling Time

  Baseline and up to 12 months

• Objective Response Rate (ORR)

  12 months

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

  Baseline and up to 12 months

Study Arms (1)

Sunitinib Malate

EXPERIMENTAL

Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)

Drug: Sunitinib

Interventions

Sunitinib DRUG

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

Also known as: Sunitinib malate, Sutent

Sunitinib Malate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A patient will be excluded from this study if he meets any of the following criteria:
• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Pfizer: collaborator

Study Sites (45)

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Connecticut Oncology & Hematology, LLP

Torrington, Connecticut, 06790, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Cancer Care & Hematology Specialista of Chicagoland

Niles, Illinois, 60714, United States

Location

Hope Center

Terre Haute, Indiana, 47802, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

Alliance Hematology Oncology PA

Westminster, Maryland, 21157, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

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

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

NH Oncology-Hematology PA

Hooksett, New Hampshire, 03106, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Interlakes Oncology Hematology, PC

Rochester, New York, 14623, United States

Location

Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

Location

Medical Oncology Associates

Kingston, Pennsylvania, 18704, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Texas Cancer Center-Abilene(South)

Abilene, Texas, 79606, United States

Location

Texas Oncology, P.A.-Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Cancer Center

Arlington, Texas, 76014, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Oncology, P.A.-Bedford

Bedford, Texas, 76022, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Texas Onclogy, P.A.

Dallas, Texas, 75231, United States

Location

Methodist Charlton Cancer Ctr.

Dallas, Texas, 75237, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Texas Cancer Center

Denton, Texas, 76210, United States

Location

El Paso Cancer Treatment Ctr

El Paso, Texas, 79915, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology-Odessa

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, United States

Location

HOAST-Medical Dr.

San Antonio, Texas, 78229, United States

Location

Texas Oncology Cancer Center-Sugar Land

Sugar Land, Texas, 77479, United States

Location

Texas Oncology Cancer Care and Research

Waco, Texas, 76712, United States

Location

Texas Oncology, P.A.

Webster, Texas, 77598, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Onc and Hem Associates of SW VA, Inc.

Salem, Virginia, 24153, United States

Location

Puget Sound Cancer Center-Edmonds

Edmonds, Washington, 98026, United States

Location

Puget Sound Cancer Center-Seattle

Seattle, Washington, 98133, United States

Location

Northwest Cancer Specialists-Vancouver

Vancouver, Washington, 98684, United States

Location

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Guru Sonpavde
• Organization: Texas Oncology Cancer Center

Guru.Sonpavde@USOncology.com

2813327505

Study Officials

• Guru Sonpavde, MD

  US Oncology Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 25, 2018
• Results First Posted: December 8, 2016

Record last verified: 2018-09

Locations

US (45)