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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044343

Enrollment

Registered

2002-08-28

Start date

2002-09-30

Completion date

2003-10-31

Last updated

2014-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal cancer, EGFR inhibitor, lapatinib, metastatic

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.

Interventions

DRUGlapatinib

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Tumor response rate (complete or partial).	6 Months

Secondary

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026