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GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00044343
  Purpose

The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.


Condition Intervention Phase
Colorectal Cancer
Drug: lapatinib
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride Fluorouracil Lapatinib Lapatinib Ditosylate Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Tumor response rate (complete or partial). [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers [ Time Frame: 6 Month ]

Enrollment: 80
Study Start Date: September 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed informed consent.
  • Refractory Stage IV metastatic colorectal cancer.
  • Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
  • No more than one prior therapy.
  • Tumor tissue available for testing.
  • 4 weeks since first-line cancer regimen.
  • Able to swallow and retain oral medication.
  • Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
  • Adequate kidney and liver function.
  • Adequate bone marrow function.

Exclusion Criteria:

  • Pregnant or lactating female.
  • Conditions that would affect absorption of an oral drug
  • First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
  • Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
  • Severe cardiovascular disease or cardiac (heart) disease requiring a device.
  • Active infection.
  • Brain metastases.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or intravenous steroids.
  • Unresolved or unstable, serious toxicity from prior therapy.
  • Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044343

  Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
  More Information

Study ID Numbers: EGF20004
Study First Received: August 26, 2002
Last Updated: September 7, 2007
ClinicalTrials.gov Identifier: NCT00044343  
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
colorectal cancer
EGFR inhibitor
lapatinib
metastatic

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Lapatinib
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009