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Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborators:
Sanofi-Synthelabo
OSI Pharmaceuticals
Hoffmann-La Roche
Genentech, Inc.
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00123851
First received: July 25, 2005
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Neoplasm Metastasis
Drug: Tarceva (OSI-774)
Drug: Capecitabine
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 32
Study Start Date: March 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123851

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Sanofi-Synthelabo
OSI Pharmaceuticals
Hoffmann-La Roche
Genentech, Inc.
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Jeffrey A. Meyerhardt, MD Dana-Farber Cancer Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00123851     History of Changes
Other Study ID Numbers: 02-269
Study First Received: July 25, 2005
Last Updated: April 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Colorectal
Metastatic Colorectal Cancer
Oxaliplatin
Tarceva
Capecitabine
Xeloda

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases
Capecitabine
Erlotinib
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014