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

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lapatinib; Oxaliplatin

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.