Last updated: 11/04/2018 06:33:24

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

GSK study ID
EGF20004
See study documents
Clinicaltrials.gov ID
NCT00044343
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Tumor response rate (complete or partial).

Timeframe: 6 Months

Secondary outcomes:

Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers

Timeframe: 6 Month

Interventions:
  • Drug: lapatinib
    • Enrollment:
    80
    Primary completion date:
    2003-31-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Colorectal Cancer
    Product
    lapatinib
    Collaborators
    None
    Study date(s)
    September 2002 to October 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    no
    • Provide signed informed consent.
    • Refractory Stage IV metastatic colorectal cancer.
    • Pregnant or lactating female.
    • Conditions that would affect absorption of an oral drug
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Clinical Trials Call Center
    Puyallup, WA, United States, 98372
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Clinical Trials Call Center
    Billings, MT, United States, 59101
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Clinical Trials Call Center
    St. Louis, MO, United States, 63136
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Clinical Trials Call Center
    Des Moines, IA, United States, 50314
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Clinical Trials Call Center
    Levis, QC, Canada, G6V 3Z1
    Status
    Recruitment Complete
    Contact us
    Location
    GSK Clinical Trials Call Center
    Thunder Bay, ON, Canada, P7A 7T1
    Status
    Recruitment Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2003-31-10
    Actual study completion date
    2003-31-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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