Phase II Sunitinib Prog Met AIPC

Metastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599313
• Other study ID #: 05112
• Secondary ID: 2006-0012
• Status: Completed
• Phase: Phase 2
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2018
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Sunitinib
50 mg/day orally each of Days 1-28 of each 6 week cycle

Locations

Country	Name	City	State
United States	Texas Cancer Center-Abilene(South)	Abilene	Texas
United States	New York Oncology Hematology, P.C.	Albany	New York
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	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Methodist Charlton Cancer Ctr.	Dallas	Texas
United States	Texas Cancer Center at Medical City	Dallas	Texas
United States	Texas Onclogy, P.A.	Dallas	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	Texas Cancer Center	Denton	Texas
United States	Puget Sound Cancer Center-Edmonds	Edmonds	Washington
United States	El Paso Cancer Treatment Ctr	El Paso	Texas
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	NH Oncology-Hematology PA	Hooksett	New Hampshire
United States	Greater Dayton Cancer Center	Kettering	Ohio
United States	Medical Oncology Associates	Kingston	Pennsylvania
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Allison Cancer Center	Midland	Texas
United States	Cancer Care & Hematology Specialista of Chicagoland	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	Texas Oncology-Odessa	Odessa	Texas
United States	Paris Regional Cancer Center	Paris	Texas
United States	Hematology Oncology Associates	Phoenix	Arizona
United States	Cancer Centers of North Carolina	Raleigh	North Carolina
United States	Interlakes Oncology Hematology, PC	Rochester	New York
United States	St. Joseph Oncology, Inc.	Saint Joseph	Missouri
United States	Arch Medical Services, Inc. DBA The Cntr for Cancer Care & Research	Saint Louis	Missouri
United States	Onc and Hem Associates of SW VA, Inc.	Salem	Virginia
United States	HOAST-Medical Dr.	San Antonio	Texas
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Puget Sound Cancer Center-Seattle	Seattle	Washington
United States	Texas Oncology Cancer Center-Sugar Land	Sugar Land	Texas
United States	Hope Center	Terre Haute	Indiana
United States	Connecticut Oncology & Hematology, LLP	Torrington	Connecticut
United States	Northwest Cancer Specialists-Vancouver	Vancouver	Washington
United States	Texas Oncology Cancer Care and Research	Waco	Texas
United States	Texas Oncology, P.A.	Webster	Texas
United States	Alliance Hematology Oncology PA	Westminster	Maryland
United States	Yakima Valley Mem Hosp/North Star Lodge	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
US Oncology Research	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change of PSA Doubling Time	Difference of PSA doubling time between baseline and end of the treatment.	Baseline and up to 12 months
Secondary	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
Secondary	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