Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
NCT ID: NCT00387387
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2006-10-20
2009-08-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FOLFOX 6 + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
Pazopanib
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
FOLFOX 6
FOLFOX 6 treatment consists of intravenous (IV) oxaliplatin (100 milligram per meter\^2\[mg/m\^2\]), and folinic acid (400 mg/m\^2), IV 5-fluorouracil bolus (400 mg/m\^2) followed by IV 5-fluorouracil (2400 to 3000 mg/m\^2) infusion over 48 hours on Day 1 of every 14-day cycle.
CapeOx + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with CapeOx. CapeOx treatment consisted of IV oxaliplatin (130 mg/m\^2) on Day 1 plus oral capecitabine (1000 mg/m\^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment was administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine was reduced to 850 mg/m\^2 twice daily.
Pazopanib
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
CapeOx
CapeOx treatment consists of IV oxaliplatin (130 mg/m\^2) on Day 1 plus oral capecitabine (1000 mg/m\^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment will be administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine will be reduced to 850 mg/m\^2 twice daily.
Interventions
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Pazopanib
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
FOLFOX 6
FOLFOX 6 treatment consists of intravenous (IV) oxaliplatin (100 milligram per meter\^2\[mg/m\^2\]), and folinic acid (400 mg/m\^2), IV 5-fluorouracil bolus (400 mg/m\^2) followed by IV 5-fluorouracil (2400 to 3000 mg/m\^2) infusion over 48 hours on Day 1 of every 14-day cycle.
CapeOx
CapeOx treatment consists of IV oxaliplatin (130 mg/m\^2) on Day 1 plus oral capecitabine (1000 mg/m\^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment will be administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine will be reduced to 850 mg/m\^2 twice daily.
Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy for metastatic disease.
* Presence of radiologically and/or clinically documented disease.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate bone marrow, hepatic, renal function, Urine Creatinine Ratio (UPC) of \<
* A female subject must not be pregnant or breast feeding.
* Able to swallow and retain oral medications.
Exclusion Criteria
* Prior treatment with pazopanib, or oxaliplatin.
* Known contraindications to the use of oxaliplatin, capecitabine, 5-fluorouracil, or folinic acid.
* Participation in any investigational study within 28 days prior to study treatment.
* Women who are pregnant or lactating.
* Poorly controlled hypertension.
* A history of cardiovascular disease, arrhythmias, or significant ECG abnormalities.
* Any history of stroke.
* Current use of therapeutic warfarin.
* Known brain metastases.
* History of disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel.
* Active infections or other serious illness.
* History of allergy to platinum compounds or heparin.
* Poor venous access.
21 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hyderabad, Andhra Pradesh, , India
GSK Investigational Site
Pārel, , India
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom
GSK Investigational Site
Sutton, Surrey, United Kingdom
Countries
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References
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Brady J, Corrie P, Chau I, Digumarti R, Adams LM, Botbyl J, Laubscher KH, Midgley RS, Mallath M. An open-label study of the safety and tolerability of pazopanib in combination with FOLFOX6 or CapeOx in patients with colorectal cancer. Invest New Drugs. 2013 Oct;31(5):1228-35. doi: 10.1007/s10637-013-9938-7. Epub 2013 Feb 28.
Other Identifiers
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VEG105424
Identifier Type: -
Identifier Source: org_study_id