NCT00032110

Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

A Phase II Study of OSI-774 in Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or metastatic colorectal cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of erlotinib, in terms of response rate and duration of stable disease, in patients with recurrent or metastatic colorectal cancer. II. Determine the toxicity of this drug in these patients. III. Determine the time to progression and response duration in patients treated with this drug. IV. Determine the relationships between clinical, pharmacokinetic, and pharmacodynamic effects of this drug in these patients. V. Correlate baseline and post-treatment levels of epidermal growth factor receptor, its downstream signaling components, markers of angiogenesis, and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after CR is confirmed. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4-8 months.

Conditions

• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given orally
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-01-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2003-01-27
• Last updated: 2015-04-15

Locations

1 site across 1 country: Canada