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

NCT01004159 | Terminated Phase 2 Results DMC

• 1 other identifier: I 152009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; KRAS wild type tumors

Outcome Measures

Primary Outcomes (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

  12 week

Secondary Outcomes (1)

• Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population

  18 months

Study Arms (1)

cetuximab with irinotecan

EXPERIMENTAL

Drug: cetuximab with irinotecan

Interventions

cetuximab with irinotecan DRUG

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

cetuximab with irinotecan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• WenWee Ma, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 19, 2015
• Results First Posted: May 16, 2014

Record last verified: 2015-09

Locations

US (1)