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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387387
First received: October 11, 2006
Last updated: May 31, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Neoplasms, Colorectal
Colorectal Cancer
Drug: pazopanib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Pharmacokinetic Study of the Safety and Tolerability of Pazopanib in Combination With FOLFOX 6 orCapeOx in Subjects With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Time Frame: on Day 1, 14 and 21 ]

Secondary Outcome Measures:
  • 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 [ Time Frame: collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1. ]

Enrollment: 70
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pazopanib
    Other Name: pazopanib
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387387

Locations
India
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
GSK Investigational Site
Parel, India, 400012
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00387387     History of Changes
Other Study ID Numbers: VEG105424
Study First Received: October 11, 2006
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pharmacokinetics
colorectal cancer
pazopanib
capecitabine
CapeOx
5-fluorouracil
oxaliplatin
combination therapy
FOLFOX 6

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014