Clinical trial NCT00387387: Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)
Official title: An Open-Label, Pharmacokinetic Study of the Safety and Tolerability of Pazopanib in Combination With FOLFOX 6 or CapeOx in Subjects With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Colorectal
Keywords: pharmacokinetics
colorectal cancer
pazopanib
capecitabine
CapeOx
5-fluorouracil
oxaliplatin
combination therapy
FOLFOX 6
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Plasma AUC(0-24) of pazopanib on Day 1, 14 and 21 Plasma AUC(0-46) of 5-FU and AUC(0-8) of platinum on Day 1 Plasma AUC(0-24) of capecitabine, 5-FU, and platinum on Day 1
timeFrame: on Day 1, 14 and 21
Secondary outcomes:
measure: Pharmacokinetic endpoints (AUC, C24, Cmax, tmax, and half-life)collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1. Assessment of disease by imaging
timeFrame: collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1.
Other outcomes:
Locations:
city: Hyderabad, Andhra Pradesh
country: India
facility: GSK Investigational Site
city: Parel
country: India
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
state: Oxfordshire
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.