Clinical trial NCT00113529: Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
Official title: A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Renal Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-06-09
Enrollment: 42
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 assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed renal cell carcinoma with metastases
* Evidence of unidimensionally measurable disease
* Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC

Exclusion Criteria:

* RCC without any clear (conventional) cell component
* History of or known brain metastases
* Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry

Primary outcomes:
measure: Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Secondary outcomes:
measure: Time to Tumor Response (TTR)
timeFrame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
measure: Duration of Response (DR)
timeFrame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
measure: Time to Tumor Progression (TTP)
timeFrame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
measure: Overall Survival (OS)
timeFrame: From start of study treatment until death
measure: Progression-Free Survival (PFS)
timeFrame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
measure: Probability of Survival at One Year
timeFrame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
measure: VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline
timeFrame: Baseline (Cycle 1, Day 1)
measure: VEGF Ratio to Baseline at Each Time Point
timeFrame: Baseline to Cycle 3, Day 28 inclusive
measure: VEGF-C Concentration at Baseline
timeFrame: Baseline (Cycle 1, Day 1)
measure: VEGF-C Ratio to Baseline at Each Time Point
timeFrame: Baseline to Cycle 3, Day 28 inclusive
measure: Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
timeFrame: Baseline (Cycle 1, Day 1)
measure: sVEGFR2 Ratio to Baseline at Each Time Point
timeFrame: Baseline to Cycle 3, Day 28 inclusive
measure: Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline
timeFrame: Baseline (Cycle 1, Day 1)
measure: sVEGFR3 Ratio to Baseline at Each Time Point
timeFrame: Baseline to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median
timeFrame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
measure: Trough Plasma Concentrations (Ctrough) of Sunitinib
timeFrame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
measure: Ctrough of SU-012662 (Sunitinib's Metabolite)
timeFrame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
measure: Ctrough of Gefitinib
timeFrame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Motzer RJ, Hudes GR, Ginsberg MS, Baum MS, Harmon CS, Kim ST, Chen I, Redman BG. Phase I/II trial of sunitinib plus gefitinib in patients with metastatic renal cell carcinoma. Am J Clin Oncol. 2010 Dec;33(6):614-8. doi: 10.1097/COC.0b013e3181c4454d.