Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer

Pfizer107 enrolled

Overview

To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Carcinoma, Renal Cell Metastasis

Interventions

SU011248 (sunitinib)DRUG

37.5 mg/day, oral, continuous daily dosing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven renal cell carcinoma with metastases. * Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST). * Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated with IFN-á alone must have received IFN-á for at least 4 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1. * Adequate organ function Exclusion Criteria: * Prior treatment with any systemic therapy other than 1 cytokine-based therapy. * Previous treatment on a SU011248 (sunitinib) clinical trial. * Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment. * Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months. * History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan. * Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval \>450 msec for males or \>470 msec for females. * Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy). * Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). * Known human immunodeficiency virus (HIV) infection.

Locations (10)

Pfizer Investigational Site

Stanford, California, United States

Pfizer Investigational Site

Las Vegas, Nevada, United States

Pfizer Investigational Site

Villejuif, France

Pfizer Investigational Site

Outcomes

Primary Outcomes

Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects

Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Secondary Outcomes

Duration of Tumor Response

Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Time to Tumor Progression (TTP)

Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Progression Free Survival (PFS)

Data from ClinicalTrials.gov

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