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ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030524
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : October 30, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of colorectal cancer.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have locally advanced or metastatic colorectal cancer that has not responded to chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: gefitinib Phase 2

Detailed Description:


  • Determine the progression-free rate at 16 weeks, response rate, time to treatment failure, and survival of patients treated with gefitinib for locally advanced or metastatic colorectal adenocarcinoma that is refractory to fluorouracil, irinotecan, and capecitabine.
  • Correlate the pharmacodynamic effects of this drug with indices of clinical benefit (e.g., tumor growth inhibition, time to tumor progression, and survival) in these patients.
  • Determine whether the status of epidermal growth factor receptor activation and signaling are predictive of clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 5-12 months.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical, Biological and Pharmacological Study of ZD1839 in Patients With Advanced Colorectal Carcinoma Refractory to 5-Fluorouracil (5-FU) and Irinotecan Chemotherapy
Study Start Date : January 2002
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed colorectal adenocarcinoma

    • Metastatic or locally advanced disease
    • Not amenable to curative therapy
  • Documentation of disease progression within the past 6 months
  • Previously treated with fluoropyrimidine- and irinotecan-based chemotherapy (including capecitabine) administered either concurrently (no more than 2 regimens) or sequentially (no more than 3 regimens) for advanced disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No known brain metastases



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 3 times ULN (5 times ULN if liver metastasis present)


  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • No significant ophthalmic conditions, including:

    • Severe dry-eye syndrome
    • Keratoconjunctivitis sicca
    • Sjogren's syndrome
    • Severe-exposure keratopathy
    • Disorders that may increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)


  • Able to take oral gefitinib
  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No prior gastrointestinal disorders (e.g., malabsorption syndrome)
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to gefitinib
  • No other prior malignancy except carcinoma in situ of the cervix, nonmelanoma skin cancer, or other cancer from which the patient has been free of evident disease for more than 5 years and/or has less than a 20-30% estimated likelihood of recurrence
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • At least 30 days since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified


  • Not specified


  • No prior gastric resection


  • No other prior therapy for advanced disease
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030524

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United States, Texas
Institute for Drug Development
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
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Study Chair: Chris H. Takimoto, MD, PhD The University of Texas Health Science Center at San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00030524    
Other Study ID Numbers: CDR0000069174
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Keywords provided by The University of Texas Health Science Center at San Antonio:
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action