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Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00026299
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of colorectal cancer. Combining chemotherapy with gefitinib may kill more tumor cells.

PURPOSE: Phase I/II trial to compare the effectiveness of chemotherapy with or without gefitinib in treating patients who have metastatic or locally recurrent colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: ZD1839 Drug: oxaliplatin Phase 1 Phase 2

Detailed Description:


  • Determine the recommended phase II dose of gefitinib when administered in combination with oxaliplatin in patients with metastatic or locally recurrent colorectal cancer.
  • Determine the dose-limiting toxicity of this regimen in these patients.
  • Compare the time to progression, objective response rate, and median and overall survival in patients treated with oxaliplatin with or without gefitinib.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a phase I dose-escalation study of gefitinib followed by a phase II randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-2).

  • Phase I: Patients receive oxaliplatin IV over 2 hours on day 1 and oral gefitinib once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients are randomized to one of two treatment arms.

    • Arm I: Patients receive oxaliplatin IV over 2 hours on day 1.
    • Arm II: Patients receive oxaliplatin as in arm I and oral gefitinib once daily at the MTD on days 1-21.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive gefitinib alone until disease progression.

PROJECTED ACCRUAL: Approximately 77 patients (9 for phase I and 68 for phase II) will be accrued for this study within 12-14 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/ Randomized Phase II Trial Of Oxaliplatin (NSC #266046) With Or Without ZD 1839 (NSC # 715055) In Patients With Advanced Colorectal Carcinoma
Study Start Date : September 2001
Primary Completion Date : December 2002
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Phase 2: Oxaliplatin plus ZD1839
Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 and ZD1839 will be taken orally at a dose of 250 mg or 500 mg daily (as determined during phase 1). Subjects can continue to receive the combination for 6 cycles (each cycle is 21 days). After 6 cycles of the combination, subjects can continue to take ZD1839 alone until their cancer worsens.
Drug: ZD1839
Other Name: gefitinib, Iressa ®
Drug: oxaliplatin
Other Name: Eloxatin ®
Experimental: Phase 2: Oxaliplatin alone
Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 for up to 6 cycles. Each cycle will last 21 days.
Drug: oxaliplatin
Other Name: Eloxatin ®
Experimental: Phase I: Oxaliplatin with ZD1839
Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2. ZD1839 will be taken orally at a dose of 250 mg or 500 mg daily.
Drug: ZD1839
Other Name: gefitinib, Iressa ®
Drug: oxaliplatin
Other Name: Eloxatin ®

Primary Outcome Measures :
  1. Recommended dose of ZD1839 in combination with oxaliplatin [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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


  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection
  • Metastatic or locally recurrent disease
  • Tumor in liver or lung accessible to needle biopsy by ultrasound or CT scan guidance
  • At least 1 measurable lesion

    • At least 20 mm by conventional techniques, including physical examination, CT scan, or MRI OR
    • At least 10 mm by spiral CT scan
    • Lesions on colonoscopic examination or barium studies, bone metastases, CNS lesions, and ascites are not considered measurable
  • Failed prior therapy with fluorouracil, leucovorin calcium, and irinotecan given either sequentially or in combination
  • No known brain metastases



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


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


  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy greater than grade 1
  • No other concurrent uncontrolled illness that would preclude study
  • No concurrent psychiatric illness or social situation that would preclude study
  • No ongoing or active infection
  • No prior allergic reaction to compounds of similar chemical or biologic composition to oxaliplatin or gefitinib
  • No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless considered to be at less than 30% risk of relapse after completion of therapy


Biologic therapy:

  • No prior epidermal growth factor inhibitor
  • At least 24 hours since prior colony-stimulating factors
  • No concurrent colony-stimulating factors during first course of study therapy


  • See Disease Characteristics
  • No more than 2 prior chemotherapy regimens for metastatic disease
  • Prior adjuvant chemotherapy allowed
  • At least 4 weeks since prior cytotoxic chemotherapy and recovered
  • No prior cisplatin or oxaliplatin

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • See Disease Characteristics
  • At least 4 weeks since prior surgery


  • At least 30 days since prior investigational agents
  • Recovered from prior therapy
  • No concurrent anti-retroviral therapy for HIV
  • No other concurrent investigational or commercial agents or therapies for 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 ClinicalTrials.gov identifier (NCT number): NCT00026299

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Loyola University Medical Center
Maywood, Illinois, United States, 60153-5589
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Michigan
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States, 49085
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Study Chair: Hedy L. Kindler, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00026299     History of Changes
Other Study ID Numbers: 11089A
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
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