Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
Neoplasms, Colorectal
About this trial
This is an interventional treatment trial for Neoplasms, Colorectal focused on measuring pharmacokinetics, colorectal cancer, pazopanib, capecitabine, CapeOx, 5-fluorouracil, oxaliplatin, combination therapy, FOLFOX 6
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of locally advanced or metastatic colorectal cancer.
- 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:
- Has had any major surgery, chemotherapy, hormone therapy, investigational agent, or radiotherapy within the last 28 days
- 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
FOLFOX 6 + Pazopanib
CapeOx + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
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.