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

NCT00387387 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-17

No results posted yet for this study

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.

Conditions

  • Neoplasms, Colorectal

Interventions

DRUG

Pazopanib

Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases

DRUG

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.

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-20
Primary Completion
2009-08-14
Completion
2009-08-14

Countries

  • India
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387387 on ClinicalTrials.gov