Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
|Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer||Drug: erlotinib hydrochloride Other: pharmacological study Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of OSI-774 in Metastatic Colorectal Cancer|
- Objective response or disease stabilization [ Time Frame: Up to 5 years ]
- Molecular changes with therapy [ Time Frame: Up to 5 years ]Will be examined using logistic regression or Fisher's exact tests as appropriate.
|Study Start Date:||January 2002|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a CR receive 2 additional courses after CR is confirmed.
Drug: erlotinib hydrochloride
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032110
|Princess Margaret Hospital Phase 2 Consortium|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza||Princess Margaret Hospital Phase 2 Consortium|