Clinical trial NCT00076011: Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
Official title: Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-01-14
Enrollment: 52
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 primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.


Eligibility criteria: Inclusion Criteria:

* Histologically documented RCC with metastases.
* Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity

Exclusion Criteria:

* Any prior systemic treatment for Renal Cell Carcinoma \[RCC\] other than 1 prior cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an anti-angiogenesis agent are not allowed.
* Inability to take oral medication

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Secondary outcomes:
measure: Time to Disease Progression (TTP)
timeFrame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
measure: Duration of Response (DR)
timeFrame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
measure: Overall Survival (OS)
timeFrame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
timeFrame: Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose
Other outcomes:
measure: Population Pharmacokinetics of Axitinib (AG-013736)
timeFrame: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks
Locations:
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
state: Paris
city: Hannover
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Rixe O, Bukowski RM, Michaelson MD, Wilding G, Hudes GR, Bolte O, Motzer RJ, Bycott P, Liau KF, Freddo J, Trask PC, Kim S, Rini BI. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007 Nov;8(11):975-84. doi: 10.1016/S1470-2045(07)70285-1. Epub 2007 Oct 23.