Clinical trial NCT00137423: Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
Official title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell Metastasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
Secondary outcomes:
measure: Duration of Tumor Response
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
measure: Time to Tumor Progression (TTP)
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
measure: Progression Free Survival (PFS)
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
measure: Overall Survival
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
measure: Summary of FACIT Fatigue Scale Overall Score
timeFrame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
measure: Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index
timeFrame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
measure: Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score
timeFrame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Pfizer Investigational Site
state: California
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
state: Gld
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
citation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
citation: Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
citation: Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, Fountzilas G, Peschel C, Flodgren P, Maneval EC, Chen I, Vogelzang NJ. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009 Sep 1;27(25):4068-75. doi: 10.1200/JCO.2008.20.5476. Epub 2009 Aug 3.