Phase II Sunitinib Prog Met AIPC

NCT ID: NCT00599313

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-06-30

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.

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.

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib Malate

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

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

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

Interventions

Sunitinib

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

Intervention Type: DRUG

Other Intervention Names

Sunitinib malate; Sutent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

US Oncology Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guru Sonpavde, MD

Role: PRINCIPAL_INVESTIGATOR

US Oncology Research

Locations

Hematology Oncology Associates

Phoenix, Arizona, United States

Connecticut Oncology & Hematology, LLP

Torrington, Connecticut, United States

Ocala Oncology Center

Ocala, Florida, United States

Cancer Care & Hematology Specialista of Chicagoland

Niles, Illinois, United States

Hope Center

Terre Haute, Indiana, United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

Alliance Hematology Oncology PA

Westminster, Maryland, United States

Missouri Cancer Associates

Columbia, Missouri, United States

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, United States

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

St Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

NH Oncology-Hematology PA

Hooksett, New Hampshire, United States

New Mexico Cancer Care Associates

Santa Fe, New Mexico, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

Interlakes Oncology Hematology, PC

Rochester, New York, United States

Cancer Centers of North Carolina

Raleigh, North Carolina, United States

Greater Dayton Cancer Center

Kettering, Ohio, United States

Medical Oncology Associates

Kingston, Pennsylvania, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Texas Cancer Center-Abilene(South)

Abilene, Texas, United States

Texas Oncology, P.A.-Amarillo

Amarillo, Texas, United States

Texas Cancer Center

Arlington, Texas, United States

Texas Oncology Cancer Center

Austin, Texas, United States

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, United States

Texas Oncology, P.A.-Bedford

Bedford, Texas, United States

Texas Cancer Center at Medical City

Dallas, Texas, United States

Texas Onclogy, P.A.

Dallas, Texas, United States

Methodist Charlton Cancer Ctr.

Dallas, Texas, United States

Texas Oncology, P.A.

Dallas, Texas, United States

Texas Cancer Center

Denton, Texas, United States

El Paso Cancer Treatment Ctr

El Paso, Texas, United States

Texas Oncology, P.A.

Fort Worth, Texas, United States

Allison Cancer Center

Midland, Texas, United States

Texas Oncology-Odessa

Odessa, Texas, United States

Paris Regional Cancer Center

Paris, Texas, United States

HOAST-Medical Dr.

San Antonio, Texas, United States

Texas Oncology Cancer Center-Sugar Land

Sugar Land, Texas, United States

Texas Oncology Cancer Care and Research

Waco, Texas, United States

Texas Oncology, P.A.

Webster, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Onc and Hem Associates of SW VA, Inc.

Salem, Virginia, United States

Puget Sound Cancer Center-Edmonds

Edmonds, Washington, United States

Puget Sound Cancer Center-Seattle

Seattle, Washington, United States

Northwest Cancer Specialists-Vancouver

Vancouver, Washington, United States

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, United States

Countries

United States

Other Identifiers

2006-0012

Identifier Type: OTHER

Identifier Source: secondary_id

05112

Identifier Type: -

Identifier Source: org_study_id