Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer

April 28, 2015 updated by: Peter Kozuch

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

To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer. Time to tumor progression, objective response rate, time to confirmed response rate, duration of confirmed response rate, time to treatment failure, and CEA response will be assessed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 > 100,000/mm3.
  • 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 targeted
  • 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 arrhythmias
  • 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 met).
  • Prior invasive malignancies for less 5 years
  • Known to be HIV positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer
Time Frame: Time to tumor progression, time to confirmed response rate, time to treatment failure, .
Time to tumor progression, time to confirmed response rate, time to treatment failure, .

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the qualitative and quantitative toxicity of this combination and sequence of drug administration
Time Frame: Objective response rate, duration of confirmed response rate, CEA response will be assessed.
Objective response rate, duration of confirmed response rate, CEA response will be assessed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Kozuch

Collaborators

Hoffmann-La Roche
Genentech, Inc.

Investigators

  • Principal Investigator: Peter Kozuch, MD, Continuum Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 12, 2007

First Posted (Estimate)

April 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022-03
  • XEL308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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