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

Primary Purpose

Neoplasms, Colorectal

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pazopanib
FOLFOX 6
CapeOx
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Colorectal focused on measuring pharmacokinetics, colorectal cancer, pazopanib, capecitabine, CapeOx, 5-fluorouracil, oxaliplatin, combination therapy, FOLFOX 6

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FOLFOX 6 + Pazopanib

CapeOx + Pazopanib

Arm Description

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

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.

Outcomes

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

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

Full Information

First Posted
October 11, 2006
Last Updated
November 13, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00387387
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 20, 2006 (Actual)
Primary Completion Date
August 14, 2009 (Actual)
Study Completion Date
August 14, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Colorectal
Keywords
pharmacokinetics, colorectal cancer, pazopanib, capecitabine, CapeOx, 5-fluorouracil, oxaliplatin, combination therapy, FOLFOX 6

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOLFOX 6 + Pazopanib
Arm Type
Experimental
Arm Description
Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
Arm Title
CapeOx + Pazopanib
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Intervention Description
Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases
Intervention Type
Drug
Intervention Name(s)
FOLFOX 6
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CapeOx
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hyderabad, Andhra Pradesh
ZIP/Postal Code
500482
Country
India
Facility Name
GSK Investigational Site
City
Parel
ZIP/Postal Code
400012
Country
India
Facility Name
GSK Investigational Site
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23456563
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.
Results Reference
derived

Learn more about this trial

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

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