Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Pfizer
Study ID
NCT00631371
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg intravenous (IV) q8wks
  • Temsirolimus — DRUG
    Temsirolimus 25 mg IV weekly
  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg intravenous (IV) q8wks
  • Interferon-Alfa 9MU — DRUG
    Interferon-Alfa 9MU SC TIW

Study Details

Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Key Dates

First listed
Mar 7, 2008
Start date
Apr 30, 2008
Status verified
Mar 2016
Primary completion
Apr 30, 2012
Completion
Apr 30, 2015

Study Design

Enrollment
791 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
  • Active Comparator: 2
    Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW

Primary Outcome Measure

Progression-Free Survival (PFS): Independent-Assessment [ Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Hematology Oncology Services of ArkansasLittle RockArkansas72205-
South County Hematology/OncologyChula VistaCalifornia91911-
Cancer Center Oncology Medical GroupLa MesaCalifornia91942-
UCLALos AngelesCalifornia90095-6984-
UCLALos AngelesCalifornia90095-
UCLA Medical CenterLos AngelesCalifornia90095-1694-
North County Oncology Medical ClinicOceansideCalifornia92056-
Medical Oncology Associates - SDSan DiegoCalifornia92123-
Sharp Memorial Hospital Investigational PharmacySan DiegoCalifornia92123-
Sharp Rees-StealySan DiegoCalifornia92123-
California Pacific Medical CenterSan FranciscoCalifornia94115-
Cohen & Hufford MD's INCSan FranciscoCalifornia94118-
Pacific Hematology/Oncology AssociatesSan FranciscoCalifornia94115-
San Francisco Oncology AssociatesSan FranciscoCalifornia94115-
The Jones Clinic, PCNew AlbanyMississippi38652-
The Cleveland ClinicClevelandOhio44195-
Edmond Oncology CenterEdmondOklahoma73034-
OU Medical CenterOklahoma CityOklahoma73104-
OU Physician's BuildingOklahoma CityOklahoma73104-
University of OklahomaOklahoma CityOklahoma73104-
The Jones Clinic, PCGermantownTennessee38138-
The Vanderbilt ClinicNashvilleTennessee37232-
Seattle Cancer Care AllianceSeattleWashington98109-1023-
University of Washington Medical CenterSeattleWashington96195-
Virginia Mason Medical CenterSeattleWashington98101-

Find similar trials in Little Rock, AR

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Hematology Oncology Services of Arkansas· Little Rock, ARSouth County Hematology/Oncology· Chula Vista, CACancer Center Oncology Medical Group· La Mesa, CAUCLA· Los Angeles, CAUCLA Medical Center· Los Angeles, CANorth County Oncology Medical Clinic· Oceanside, CA

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