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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate (complete or partial).

Outcome Time Frame:

6 Months

Principal Investigator

GSK Clinical Trial, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF20004

NCT ID:

NCT00044343

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • EGFR inhibitor
  • lapatinib
  • metastatic
  • Colorectal Neoplasms

Name

Location

GSK Clinical Trials Call CenterChula Vista, California  91911
GSK Clinical Trials Call CenterNorwich, Connecticut  06360
GSK Clinical Trials Call CenterGainesville, Florida  32610
GSK Clinical Trials Call CenterAtlanta, Georgia  30328
GSK Clinical Trials Call CenterEvansville, Indiana  47713
GSK Clinical Trials Call CenterNew Orleans, Louisiana  70112
GSK Clinical Trials Call CenterFrederick, Maryland  21701
GSK Clinical Trials Call CenterPittsfield, Massachusetts  01201
GSK Clinical Trials Call CenterSt. Louis, Missouri  63141
GSK Clinical Trials Call CenterVoorhees, New Jersey  08043
GSK Clinical Trials Call CenterAlbany, New York  12208
GSK Clinical Trials Call CenterCleveland, Ohio  44106-5065
GSK Clinical Trials Call CenterLemoyne, Pennsylvania  17043
GSK Clinical Trials Call CenterColumbia, South Carolina  29203
GSK Clinical Trials Call CenterMemphis, Tennessee  38119
GSK Clinical Trials Call CenterOlympia, Washington  98506
GSK Clinical Trials Call CenterDes Moines, Iowa  50314
GSK Clinical Trials Call CenterBillings, Montana  59101
GSK Clinical Trials Call CenterOmaha, Nebraska  68198-7680
GSK Clinical Trials Call CenterHooksett, New Hampshire  03106-2505
GSK Clinical Trials Call CenterCharlotte, North Carolina  28203