Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
NCT ID: NCT00599924
Last Updated: 2015-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2005-09-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
SU011248 \[sunitinib\] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle.
25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion
sunitinib + FOLFOX
37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
sunitinib + FOLFOX
50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
sunitinib + FOLFOX
50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)
sunitinib + FOLFOX
37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
sunitinib + FOLFOX
50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
sunitinib + FOLFOX
37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
sunitinib + FOLFOX
25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
Interventions
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sunitinib + FOLFOX
37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
sunitinib + FOLFOX
50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
sunitinib + FOLFOX
50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)
sunitinib + FOLFOX
37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
sunitinib + FOLFOX
50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
sunitinib + FOLFOX
37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
sunitinib + FOLFOX
25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
* Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
* For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181048
Identifier Type: -
Identifier Source: org_study_id
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