Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)

• Status: Completed
• Trial end date: 2009-08-14
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the safety of treating colorectal cancer with a combination of drugs. The current standard treatments of FOLFOX6 or CapeOx will be give in combination with the GSK investigational drug pazopanib.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Capecitabine; Fluorouracil; Oxaliplatin

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.