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Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan

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: NCT01004159
Recruitment Status : Terminated (former PI left institute)
First Posted : October 29, 2009
Results First Posted : May 16, 2014
Last Update Posted : October 19, 2015
Bristol-Myers Squibb
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: cetuximab with irinotecan Phase 2

Detailed Description:

Cetuximab is a manufactured antibody-antibodies are proteins that can be found circulating in your blood stream. The growth of colorectal cancer may be affected by the interaction of a growth factor known as "epidermal growth factor" (EGF) with its receptor.

Cetuximab is a antibody directed against the receptor for EGF and has been shown to turn off the activity of the receptor and to stop the growth of cancer cells in many laboratory tests. Cetuximab has been recently approved by the Food and Drug Administration in the treatment of patients with advanced colorectal cancer and who failed standard chemotherapy. Cetuximab has been shown to delay the progression of colorectal cancer when given alone in patients who have failed standard chemotherapy and when given with a chemotherapy drug called irinotecan in patients who have failed irinotecan.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of High Dose Cetuximab Plus Irinotecan in Colorectal Cancer Patients With KRS-Wild Type Tumors Who Progressed After Failure of Prior Standard Dose ofCetuximab Plus Irinotecan
Study Start Date : September 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: cetuximab with irinotecan Drug: cetuximab with irinotecan
Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment

Primary Outcome Measures :
  1. 12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer [ Time Frame: 12 week ]

Secondary Outcome Measures :
  1. Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population [ Time Frame: 18 months ]

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

Inclusion Criteria:

  • Histologically confirmed colon cancer that is metastatic or unresectable
  • Progressed on cetuximab plus irinotecan based combination prior to enrolling on this study
  • Patient must have tumor tissue tested for KRAS mutation and should be confirmed to carry a wild type
  • ECOG less than or equal to 1
  • Must have adequate organ and marrow function
  • Ability to understand and the willingness to sign a written informed consent document.
  • Presence of measurable disease defined as a lesion ≥ 2 cm by CT (or 1 cm by spiral CT). All sites of disease should be evaluated ≤ 3 weeks before treatment initiation
  • Patients should have failed or been deemed intolerant to other standard chemotherapy treatments such as oxaliplatin and fluoropyrimidines

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents that are not included in this study. Prior investigational anticancer agents wil not be allowed within 4 weeks prior to study treatment. Herbal medicine and vitamins wil not be considered as contraindications for enrollment on study.
  • Patients with known brain metastases are not eligible unless brain metastases are treated and stable on radiographic follow-up and without significant symptomatology
  • History of other invasive cancers with current evidence of disease
  • Patients should be off chemotherapy or other targeted therapies for at least 3 weeks before study treatment. Mitomycin C treatment should be at least 6 weeks before study treatment
  • History of allergic reactions to irinotecan
  • Prior severe infusion reaction to cetuximab
  • History of allergic reaction to tetracycline or doxycycline
  • Need for prior dose reduction on cetuximab secondary to grade 3 skin toxicity
  • Active skin toxicity of grade 2 or higher at the time of study enrollment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because the chemotherapeutic agents proposed are category D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated on this study.
  • Grade 2 or higher hypomagnesemia at baseline evaluation

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): NCT01004159

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Bristol-Myers Squibb
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Principal Investigator: WenWee Ma, MD Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute Identifier: NCT01004159    
Other Study ID Numbers: I 152009
First Posted: October 29, 2009    Key Record Dates
Results First Posted: May 16, 2014
Last Update Posted: October 19, 2015
Last Verified: September 2015
Keywords provided by Roswell Park Cancer Institute:
Colorectal cancer
KRAS wild type tumors
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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological