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Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With 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: NCT00087334
Recruitment Status : Terminated (Withdrawn due to poor/low accrual)
First Posted : July 12, 2004
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining capecitabine and oxaliplatin with gefitinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and gefitinib and to see how well they work in treating patients with metastatic colorectal cancer.

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

Detailed Description:



  • Determine the maximum tolerated dose of capecitabine when given in combination with oxaliplatin and gefitinib in patients with metastatic colorectal cancer. (phase I)
  • Determine the response rate in patients treated with this regimen. (phase II)


  • Determine the safety and toxic effects of this regimen in these patients.
  • Determine the 1-year survival of patients treated with this regimen. (phase II)
  • Determine the progression-free and overall survival of patients treated with this regimen. (phase II)

OUTLINE: This is an open-label, nonrandomized, phase I, dose-escalation study of capecitabine followed by a phase II study.

  • Phase I: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive oral gefitinib once daily beginning 5 days before the initiation of capecitabine and oxaliplatin and continuing for the duration of study treatment. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine 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 receive oral capecitabine (at the MTD determined in phase I), oxaliplatin IV, and oral gefitinib as in phase I.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 1-12 months; and a total of 26 patients will be accrued for the phase II portion of this study within 8-13 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Capecitabine (XELODA®, Roche) Plus Oxaliplatin (Eloxatin®, Sanofi) Plus ZD 1893 (IRESSA®) in the Treatment of Metastatic Colorectal Cancer
Study Start Date : January 2004
Actual Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Maximum tolerated dose
  2. Response rate

Secondary Outcome Measures :
  1. Toxicity
  2. 1-year survival (phase II)
  3. Progression-free survival (phase II)
  4. Overall survival in (phase II)

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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed* colorectal cancer

    • Metastatic disease
    • The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: *Confirmation is not required for recurrent metastatic disease unless an interval of > 5 years has elapsed between the initial primary surgery and the development of metastases
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No CNS metastases



  • 18 to 80

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusion allowed)


  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ ULN
  • No unstable or uncompensated hepatic disease


  • Creatinine < 1.5 times ULN OR
  • Creatinine clearance > 60 mL/min
  • No unstable or uncompensated renal disease


  • No unstable or uncompensated cardiac disease


  • No evidence of clinically active interstitial lung disease

    • Asymptomatic patients with chronic stable radiographic changes are eligible
  • No unstable or uncompensated respiratory disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No known hypersensitivity to gefitinib or any of its excipients
  • No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine
  • No severe or uncontrolled systemic disease
  • Able to receive oral medication
  • No known dihydropyrimidine dehydrogenase (DPD) deficiency
  • No known peripheral neuropathy ≥ grade 1

    • Absence of deep tendon reflexes as the sole neurological abnormality allowed
  • No other significant clinical disorder or laboratory finding that would preclude study participation
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only)


Biologic therapy

  • Not specified


  • At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I)
  • No prior chemotherapy for metastatic disease (phase II)

    • Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease
  • No prior irinotecan and oxaliplatin (phase II)

Endocrine therapy

  • Not specified


  • No concurrent radiotherapy for colorectal cancer


  • See Disease Characteristics
  • More than 4 weeks since prior major surgery (e.g., laparotomy)


  • Recovered from all prior therapy (no unresolved chronic toxicity > grade 2)
  • More than 4 weeks since prior investigational drugs
  • No prior epidermal growth factor receptor inhibitor therapy (phase II)
  • No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort)
  • No other concurrent investigational drugs
  • No other concurrent systemic therapy for colorectal cancer

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): NCT00087334

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute Identifier: NCT00087334    
Other Study ID Numbers: I 17403
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013
Keywords provided by Roswell Park Cancer Institute:
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors