A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
NCT ID: NCT00931840
Last Updated: 2011-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
220 participants
INTERVENTIONAL
2009-06-30
2012-01-31
Brief Summary
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After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.
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Detailed Description
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Approximately 220 patients will be enrolled in this study: approximately 100 patients in the K-RAS mutated arm and approximately 120 patients in the wild-type K-RAS arm.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EZN-2208
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
EZN-2208, Cetuximab and Irinotecan
Patients with mutated K RAS tumors will be treated with single-agent EZN-2208 (Arm A). PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
Patients with wild-type K-RAS tumors will be randomly assigned in a 2:1 ratio to EZN-2208 + cetuximab (Arm B) or the benchmark of irinotecan + cetuximab (Arm C).
Cetuximab + EZN-2208
Cetuximab will be administered as an i.v. infusion on weekly basis. EZN-2208 administered as i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
EZN-2208, Cetuximab and Irinotecan
Patients with mutated K RAS tumors will be treated with single-agent EZN-2208 (Arm A). PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
Patients with wild-type K-RAS tumors will be randomly assigned in a 2:1 ratio to EZN-2208 + cetuximab (Arm B) or the benchmark of irinotecan + cetuximab (Arm C).
Irinotecan + cetuximab
Cetuximab will be administered weekly as an i.v. infusion. Irinotecan will be administered as an i.v. infusion on Weeks 1 and 2 and repeated every 3 weeks.
EZN-2208, Cetuximab and Irinotecan
Patients with mutated K RAS tumors will be treated with single-agent EZN-2208 (Arm A). PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
Patients with wild-type K-RAS tumors will be randomly assigned in a 2:1 ratio to EZN-2208 + cetuximab (Arm B) or the benchmark of irinotecan + cetuximab (Arm C).
Interventions
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EZN-2208, Cetuximab and Irinotecan
Patients with mutated K RAS tumors will be treated with single-agent EZN-2208 (Arm A). PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
Patients with wild-type K-RAS tumors will be randomly assigned in a 2:1 ratio to EZN-2208 + cetuximab (Arm B) or the benchmark of irinotecan + cetuximab (Arm C).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Histologically confirmed CRC adenocarcinoma that is metastatic or locally recurrent CRC that is nonresectable
2. Patients must agree to genetic testing of the original or metastatic CRC tumor biopsy tissue for K-RAS mutational status.
3. Disease progression
4. Previous therapy with irinotecan, oxaliplatin, and fluoropyrimidine either alone or in any combination(s). Patients must have radiographically documented progressive disease while receiving, or within 3 months of receiving, these agents alone or in combination.
5. No more than 2 prior cytotoxic chemotherapy regimens.
6. Age 18 years or older
7. Measurable disease by RECIST Version 1.1
8. ECOG performance status of 0 or 1
9. Adequate bone marrow, renal, and hepatic function
Exclusion Criteria
2. Major surgery within 3 weeks before study start
3. Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy.
4. Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before the scheduled administration of EZN-2208
5. History of other primary cancer within 5 years of enrollment, unless
1. Curatively resected non-melanomatous skin cancer, or
2. Curatively resected cervical cancer
6. Lack of recovery to Grade 1 from any reversible side effects related to the administration of an investigational agent, or other prior treatments for the cancer
7. Any condition such as uncontrollable diabetes, uncontrollable hypertension, or active infection.
8. Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an approved drug) in the 30 days before the first administration of EZN-2208
18 Years
ALL
No
Sponsors
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Enzon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard M. Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Location #033
Tucson, Arizona, United States
Location# 042
Alhambra, California, United States
Location # 043
Bakersfield, California, United States
Location# 044
Fullerton, California, United States
Location# 019
La Jolla, California, United States
Location# 046
Long Beach, California, United States
Location# 053
Los Angeles, California, United States
Location# 051
Northridge, California, United States
Location# 045
Pomona, California, United States
Location # 048
Santa Barbara, California, United States
Location # 049
Santa Barbara, California, United States
Location# 052
Santa Maria, California, United States
Location #027
Stanford, California, United States
Location# 003
Newark, Delaware, United States
Location# 047
Orlando, Florida, United States
Location# 022
Port Saint Lucie, Florida, United States
Location# 005
Marietta, Georgia, United States
Location# 009
Chicago, Illinois, United States
Location #050
Terre Haute, Indiana, United States
Location# 029
Worcester, Massachusetts, United States
Location #031
Lebanon, New Hampshire, United States
Location # 030
Buffalo, New York, United States
Location# 035
New York, New York, United States
Location# 002
New York, New York, United States
Location# 007
The Bronx, New York, United States
Location# 001
Chapel Hill, North Carolina, United States
Location# 020
Goldsboro, North Carolina, United States
Location# 024
Winston-Salem, North Carolina, United States
Location# 008
Columbus, Ohio, United States
Location# 037
Lancaster, Pennsylvania, United States
Location# 018
Greenville, South Carolina, United States
Location# 004
Memphis, Tennessee, United States
Location #038
Houston, Texas, United States
Location# 011
Lubbock, Texas, United States
Location# 021
San Antonio, Texas, United States
Location# 076
Ottawa, Ontario, Canada
Location # 079
Toronto, Ontario, Canada
Location# 077
Montreal, Quebec, Canada
Location# 074
Montreal, Quebec, Canada
Location# 055
Rimouski, Quebec, Canada
Location# 066
Tel-Aviv, Central District, Israel
Location# 071
Kfar Saba, Sharon, Israel
Location# 072
Beersheba, South District, Israel
Location# 068
Be’er Ya‘aqov, , Israel
Location# 067
Haifa, , Israel
Location# 073
Jerusalem District, , Israel
Location# 070
Tel Aviv, , Israel
Location# 069
Tel Litwinsky, , Israel
Location# 041
Leiden, NL, Netherlands
Location # 040
Rotterdam, The Netherlands, Netherlands
Location #065
Dorchester, Dorset, United Kingdom
Location # 083
London, England, United Kingdom
Location# 057
London, Greater London, United Kingdom
Location# 054-2
London, Greater London, United Kingdom
Location #061
London, Greater London, United Kingdom
Location# 064
Manchester, Greater Manchester, United Kingdom
Location# 056
Edinburgh, Scotland, United Kingdom
Location# 062
Glasgow, Scotland, United Kingdom
Location# 054
Sutton, Surrey, United Kingdom
Location# 063
Leeds, West Yorkshire, United Kingdom
Countries
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Other Identifiers
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EZN-2208-04
Identifier Type: -
Identifier Source: org_study_id
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