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Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Colorectal Cancer

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Trial Information

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.

Inclusion Criteria:

- Patients who have histologically or cytologically confirmed diagnosis of
metastatic colorectal adenocarcinoma.

- Patients must be > 18 years old.

- Patients must have a performance status of > 60 on the Karnofsky scale

- Patients must have an expected life expectancy of at least 12 weeks.

- Patients must give written informed consent as per institutional and federal
regulatory requirements.

- Patients must have measurable or evaluable disease .

- Patients must have an absolute neutrophil count of > 1,500/mm3 and a platelet count >

- Patients must have adequate liver and renal function defined by a bilirubin of < 2.0
mg/dl and a creatinine of < 1.5 mg/dl, respectively.

- Patients must be able to stay in the general area for the duration of their treatment
on this clinical research study.

Exclusion Criteria:

- Prior chemotherapy, treatment with inhibitors of EGFR of any kind, molecularly

- Pregnant or lactating women

- Clinical signs of brain involvement or leptomeningeal disease

- Serious illness or medical conditions

- Congestive heart failure or unstable angina pectoris, uncontrolled hypertension or

- Active infections

- UnstaOphthalmic disorders that might increase the risk for epithelium related
complications (bullous keratopathy, aniridia, severe chemical burns, neutrophilic
keratitis e.g.)

- GI tract disease resulting in an inability to take oral medication such as
uncontrolled inflammatory GI disease (e.g. Crohn's disease, ulcerative colitis) or
post surgical malabsorption characterized by uncontrolled diarrhea that results in
weight loss and vitamin deficiency orequires IV hyperalimentation (however, use of
pancreatic enzyme supplementation is allowed provided that the above criteria are not

- Prior invasive malignancies for less 5 years

- Known to be HIV positive.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer

Outcome Time Frame:

Time to tumor progression, time to confirmed response rate, time to treatment failure, .

Safety Issue:


Principal Investigator

Peter Kozuch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Continuum Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

June 2005

Related Keywords:

  • Metastatic Colorectal Cancer
  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms



Beth Israel Medical CenterNew York, New York  10003