Clinical trial NCT00089648: SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
Official title: A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-08-11
Enrollment: 61
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: The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically proven renal cell carcinoma of clear cell histology with metastases
* Evidence of measurable disease
* Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
* Prior radical or partial nephrectomy

Exclusion Criteria:

* Prior treatment with any other anti-angiogenic therapy other than bevacizumab
* Prior systemic treatment for RCC \> 2 regimens
* History of or known brain metastases
* Serious acute or chronic illness or recent history of significant cardiac abnormality

Primary outcomes:
measure: Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Secondary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
measure: Duration of Response (DR)
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
measure: Overall Survival (OS)
timeFrame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 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 including 28 day post study follow up
measure: Trough Plasma Concentrations (Cmin) of Sunitinib
timeFrame: Day 28 of Cycle 1 to Cycle 4
measure: Trough Plasma Concentrations (Cmin) of SU012662
timeFrame: Day 28 of Cycle 1 to Cycle 4
measure: Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)
timeFrame: Day 28 of Cycle 1 to Cycle 4
measure: Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)
timeFrame: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)
measure: Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
timeFrame: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)
measure: Plasma Concentration of Placental Growth Factor (PlGF)
timeFrame: Cycle 1 (Days 1, 14, and 28)
measure: Plasma Concentration of VEGF-C
timeFrame: Cycle 1 (Days 1, 14, and 28)
measure: Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)
timeFrame: 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: