Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal Cancer

April 27, 2009 updated by: Dana-Farber Cancer Institute

A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer

This trial is designed to investigate the safety, tolerability and the effectiveness when OSI-774 (tarceva) is combined with oxaliplatin and capecitabine in treating patients with metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be treated with OSI-774 (orally) daily, oxaliplatin (intravenously) every 3 weeks, and capecitabine (orally) twice daily for 14 days followed by a 7-day rest period. This will constitute a 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.

Study Type

Interventional

Enrollment

32

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess 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:

  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients with histologic proof of adenocarcinoma of the colon or rectum (colorectal carcinoma) with evidence of metastatic disease.
  • Patients must have received one (and only 1) prior chemotherapy regimen for metastatic disease. Patients who received adjuvant therapy and then 1 regimen for metastatic disease are eligible. Patients who received adjuvant therapy and recur within 12 months of completion of adjuvant therapy are also eligible.
  • Patients who have received prior radiation therapy, either in the adjuvant or metastatic setting, for colorectal carcinoma.

  • All of the following must apply:

    • Greater than 4 weeks must have elapsed from the time of major surgery and patients must have recovered from the effects (e.g., laparotomy); *Greater than 2 weeks must have elapsed from the time of minor surgery and patients must have recovered from the operation. (Insertion of a vascular access device is not considered major or minor surgery.);
    • Greater than 4 weeks must have elapsed from the time of major radiotherapy [RT] (e.g., chest or bone palliative RT);
    • Greater than 4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities;
    • Greater than 4 weeks must have elapsed from the participation in any investigational drug study.
  • ECOG performance status < 2 ; life expectancy > 12 weeks
  • Patients must have normal organ and marrow function as defined below:

ANC > 1500/mm3; hemoglobin > 9.0 gm/dl; platelets > 100,000/mm3; SGOT < 2.5x upper limits of normal if no evidence of liver metastases or < 5x upper limits of normal if evidence of liver metastases; total bilirubin < 1.5x upper limits of normal; Alk Phos < 2.5x upper limits of normal (or < 5x upper limits of normal if evidence of liver metastases or < 10x upper limits of normal if evidence of bone disease).

Exclusion Criteria:

  • Patients with peripheral neuropathy of grade 2 or greater severity.
  • Uncontrolled high blood pressure.
  • Unstable angina.
  • Symptomatic congestive heart failure.
  • Myocardial infarction < 12 months prior to registration.
  • Serious uncontrolled cardiac arrhythmia.
  • New York Heart Association classification III or IV.
  • Active or uncontrolled infection.
  • Medical or psychiatric conditions which, in the opinion of the investigator, make participation in an investigational trial of this nature a poor risk.
  • Patients with known brain metastases or carcinomatous meningitis should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • No concurrent malignancy of any site, except for limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration and agree to use an effective method of contraception.
  • Patients who are pregnant or lactating.
  • Patients with prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
  • Patients previously treated with oxaliplatin, OSI-774 or another epidermal growth factor inhibitor (EGFR).
  • Patients lacking physical integrity of the upper gastrointestinal tract.
  • Patients with other serious uncontrolled medical conditions that the investigator feels might compromise study participation.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the response rate of OSI-774 when given in combination with oxaliplatin and capecitabine in patients with previously-treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma

Secondary Outcome Measures

Outcome Measure
To assess overall survival, progression-free survival, time to progression and duration of response
To evaluate the toxicities of the combination of OSI-774, oxaliplatin and capecitabine in this population of patients with colorectal cancer

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Hoffmann-La Roche
Genentech, Inc.
Sanofi-Synthelabo
OSI Pharmaceuticals

Investigators

  • Principal Investigator: Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute

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

March 1, 2003

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

July 25, 2005

First Submitted That Met QC Criteria

July 25, 2005

First Posted (Estimate)

July 26, 2005

Study Record Updates

Last Update Posted (Estimate)

April 28, 2009

Last Update Submitted That Met QC Criteria

April 27, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-269

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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