Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer
Approximately 150,000 people are diagnosed with colorectal cancer in the United States each
year. Forty to fifty thousand people eventually will develop metastatic colorectal cancer
and 40,000 people die annually because of advanced or metastatic colorectal cancer. Cancer
patients prefer oral therapy over intravenous therapy as palliative treatment if efficacy
regarding response rate and response duration is not compromised. Therefore, development of
a completely oral combination therapy that approximates or improves upon the clinical
outcomes attained by the reference triple drug therapies should be a research priority.
Compared with intravenous 5-fluourouracil/leucovorin as first-line treatment for metastatic
colorectal cancer, oral capecitabine has demonstrated similar survival outcomes
(approximately 12-13 months), response rates (15-20%), and response durations (4-5 months)
in two multi-institutional international randomized phase III trials. Erlotinib (OSI-774,
Tarceva) is an orally available inhibitor of human EGFR tyrosine kinase. The epidermal
growth factor receptor (EGFR) is overexpressed in a variety of human cancers including
colorectal cancer. The principal goal of anticancer treatment with tyrosine kinase
inhibitors such as erlotinib is to restore normal cellular growth by interrupting EGFR
mediated cell proliferation and malignant The hypothesis of this phase II trial is that the
unique mechanisms of action and non-overlapping toxicity profiles of capecitabine (Xeloda)
and erlotinib will allow these drugs to be combined into a safe and tolerable regimen with
better activity regarding response, response duration, and median survival than capecitabine
alone in patients with previously untreated metastatic colorectal cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer
Time to tumor progression, time to confirmed response rate, time to treatment failure, .
Yes
Peter Kozuch, MD
Principal Investigator
Continuum Cancer Center
United States: Food and Drug Administration
022-03
NCT00459901
June 2004
June 2005
Name | Location |
---|---|
Beth Israel Medical Center | New York, New York 10003 |