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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Neoplasms, Colorectal

Treatments: Drug: CapeOx; Drug: Pazopanib; Drug: FOLFOX 6

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387387

VEG105424

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

FOLFOX 6 + Pazopanib

Experimental group

Description:

Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.

Treatment:

Drug: FOLFOX 6

Drug: Pazopanib

CapeOx + Pazopanib

Experimental group

Description:

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.

Treatment:

Drug: CapeOx

Drug: Pazopanib