Clinical trial NCT00599313: Phase II Sunitinib Prog Met AIPC
Official title: Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Prostate Cancer
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-01-23
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Median Progression-free Survival (PFS) Time at 1-year.
timeFrame: 12 months
Secondary outcomes:
measure: Overal Survival (OS) Rate at 1-year.
timeFrame: 12 months
measure: Prostate Specific Antigen (PSA) Response
timeFrame: Baseline and up to 12 months
measure: Change of PSA Doubling Time
timeFrame: Baseline and up to 12 months
measure: Objective Response Rate (ORR)
timeFrame: 12 months
measure: Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.
timeFrame: Baseline and up to 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Torrington
country: United States
facility: Connecticut Oncology & Hematology, LLP
state: Connecticut
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Niles
country: United States
facility: Cancer Care & Hematology Specialista of Chicagoland
state: Illinois
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Westminster
country: United States
facility: Alliance Hematology Oncology PA
state: Maryland
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Saint Joseph
country: United States
facility: St. Joseph Oncology, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Arch Medical Services, Inc. DBA The Cntr for Cancer Care & Research
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Hooksett
country: United States
facility: NH Oncology-Hematology PA
state: New Hampshire
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology Hematology, PC
state: New York
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Abilene
country: United States
facility: Texas Cancer Center-Abilene(South)
state: Texas
city: Amarillo
country: United States
facility: Texas Oncology, P.A.-Amarillo
state: Texas
city: Arlington
country: United States
facility: Texas Cancer Center
state: Texas
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Mamie McFaddin Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A.-Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Onclogy, P.A.
state: Texas
city: Dallas
country: United States
facility: Methodist Charlton Cancer Ctr.
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: Texas Oncology-Odessa
state: Texas
city: Paris
country: United States
facility: Paris Regional Cancer Center
state: Texas
city: San Antonio
country: United States
facility: HOAST-Medical Dr.
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology Cancer Center-Sugar Land
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care and Research
state: Texas
city: Webster
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Onc and Hem Associates of SW VA, Inc.
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Center-Edmonds
state: Washington
city: Seattle
country: United States
facility: Puget Sound Cancer Center-Seattle
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists-Vancouver
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Mem Hosp/North Star Lodge
state: Washington
Study officials:
affiliation: US Oncology Research
name: Guru Sonpavde, MD
role: PRINCIPAL_INVESTIGATOR
References: