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GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

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ClinicalTrials.gov Identifier: NCT00044343
Recruitment Status : Completed
First Posted : August 28, 2002
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: lapatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2002
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT00044343


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00044343     History of Changes
Other Study ID Numbers: EGF20004
First Posted: August 28, 2002    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Keywords provided by GlaxoSmithKline:
colorectal cancer
EGFR inhibitor
lapatinib
metastatic

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
Oxaliplatin
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action