Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00032110|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of OSI-774 in Metastatic Colorectal Cancer|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
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: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032110
|Princess Margaret Hospital Phase 2 Consortium|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza||Princess Margaret Hospital Phase 2 Consortium|