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A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma

Primary Purpose

Metastatic Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EZN-2208, Cetuximab and Irinotecan
Sponsored by
Enzon Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring EZN-2208 (PEG-SN38)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must meet all of the following criteria to be eligible for enrollment in the study.

    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:

  • Patients meeting any of the following exclusion criteria will not be eligible for enrollment.

    1. Known chronic infectious disease
    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

Sites / Locations

  • Location #033
  • Location# 042
  • Location # 043
  • Location# 044
  • Location# 019
  • Location# 046
  • Location# 053
  • Location# 051
  • Location# 045
  • Location # 048
  • Location # 049
  • Location# 052
  • Location #027
  • Location# 003
  • Location# 047
  • Location# 022
  • Location# 005
  • Location# 009
  • Location #050
  • Location# 029
  • Location #031
  • Location# 007
  • Location # 030
  • Location# 035
  • Location# 002
  • Location# 001
  • Location# 020
  • Location# 024
  • Location# 008
  • Location# 037
  • Location# 018
  • Location# 004
  • Location #038
  • Location# 011
  • Location# 021
  • Location# 076
  • Location # 079
  • Location# 077
  • Location# 074
  • Location# 055
  • Location# 066
  • Location# 071
  • Location# 072
  • Location# 068
  • Location# 067
  • Location# 073
  • Location# 069
  • Location# 070
  • Location# 041
  • Location # 040
  • Location #065
  • Location # 083
  • Location# 057
  • Location# 054-2
  • Location #061
  • Location# 064
  • Location# 056
  • Location# 062
  • Location# 054
  • Location# 063

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

EZN-2208

Cetuximab + EZN-2208

Irinotecan + cetuximab

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Progression Free Survival (PFS)

Full Information

First Posted
June 30, 2009
Last Updated
September 19, 2011
Sponsor
Enzon Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00931840
Brief Title
A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
Official Title
A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma (mCRC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enzon Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy, safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be randomized to EZN-2208 + cetuximab or to standard of care (Camptosar® + cetuximab), patients must have failed regimens containing irinotecan (Camptosar®, CPT-11), oxaliplatin (Eloxatin®), and fluoropyrimidine. 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.
Detailed Description
EZN-2208 will be administered by i.v. infusion weekly for 3 weeks in 4-week cycles. The cetuximab infusion will be administered before the EZN-2208 (Arm B) or irinotecan (Arm C) infusion. Study treatment will be continued until evidence of disease progression, unacceptable toxicity, or withdrawal of the patient's consent for participation in the study. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
EZN-2208 (PEG-SN38)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EZN-2208
Arm Type
Experimental
Arm Description
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.
Arm Title
Cetuximab + EZN-2208
Arm Type
Experimental
Arm Description
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.
Arm Title
Irinotecan + cetuximab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EZN-2208, Cetuximab and Irinotecan
Other Intervention Name(s)
Irinotecan, (CPT 11),(Camptosar®), Erbitux (cetuximab)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
2011
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment in the study. Histologically confirmed CRC adenocarcinoma that is metastatic or locally recurrent CRC that is nonresectable Patients must agree to genetic testing of the original or metastatic CRC tumor biopsy tissue for K-RAS mutational status. Disease progression 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. No more than 2 prior cytotoxic chemotherapy regimens. Age 18 years or older Measurable disease by RECIST Version 1.1 ECOG performance status of 0 or 1 Adequate bone marrow, renal, and hepatic function Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment. Known chronic infectious disease Major surgery within 3 weeks before study start Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy. Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before the scheduled administration of EZN-2208 History of other primary cancer within 5 years of enrollment, unless Curatively resected non-melanomatous skin cancer, or Curatively resected cervical cancer 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 Any condition such as uncontrollable diabetes, uncontrollable hypertension, or active infection. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M. Goldberg, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Location #033
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Location# 042
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Location # 043
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Location# 044
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Location# 019
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Location# 046
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Location# 053
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Location# 051
City
Northridge
State/Province
California
ZIP/Postal Code
91235
Country
United States
Facility Name
Location# 045
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Location # 048
City
Santa Barbara,
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Location # 049
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Location# 052
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Location #027
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Location# 003
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Location# 047
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Location# 022
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Location# 005
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Location# 009
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
Location #050
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Location# 029
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Location #031
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Location# 007
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Location # 030
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Location# 035
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Location# 002
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Location# 001
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Location# 020
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Location# 024
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Location# 008
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Location# 037
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17605
Country
United States
Facility Name
Location# 018
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Location# 004
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Location #038
City
Houston
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Location# 011
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Location# 021
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Location# 076
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Location # 079
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C3E7
Country
Canada
Facility Name
Location# 077
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Location# 074
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Location# 055
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Location# 066
City
Tel-Aviv
State/Province
Central District
ZIP/Postal Code
69710
Country
Israel
Facility Name
Location# 071
City
Kfar Saba
State/Province
Sharon
ZIP/Postal Code
44281
Country
Israel
Facility Name
Location# 072
City
Beer Sheva
State/Province
South District
ZIP/Postal Code
84101
Country
Israel
Facility Name
Location# 068
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Location# 067
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Location# 073
City
Jerusalem District
ZIP/Postal Code
91120
Country
Israel
Facility Name
Location# 069
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Location# 070
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Location# 041
City
Leiden
State/Province
NL
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
Location # 040
City
Rotterdam
State/Province
The Netherlands
Country
Netherlands
Facility Name
Location #065
City
Dorchester
State/Province
Dorset
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Location # 083
City
London
State/Province
England
ZIP/Postal Code
W8 8RF
Country
United Kingdom
Facility Name
Location# 057
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Location# 054-2
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Location #061
City
London
State/Province
Greater London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Location# 064
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Location# 056
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Location# 062
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Location# 054
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Location# 063
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma

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