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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387387
First Posted: October 13, 2006
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: Pazopanib Drug: FOLFOX 6 Drug: CapeOx Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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: 50
Actual Study Start Date: October 20, 2006
Study Completion Date: August 14, 2009
Primary Completion Date: August 14, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFOX 6 + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
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.
Experimental: CapeOx + Pazopanib
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.
Drug: Pazopanib
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Submitted: October 11, 2006
First Posted: October 13, 2006
Last Update Posted: November 17, 2017
Last Verified: November 2017

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

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