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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01004159
• Other study ID #: I 152009
• Status: Terminated
• Phase: Phase 2
• First received: October 28, 2009
• Last updated: September 29, 2015
• Start date: September 2009
• Est. completion date: May 2012

Study information

• Verified date: September 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 week	No
Secondary	Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population		18 months	No