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A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma (mCRC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma (mCRC)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

2011

Safety Issue:

Yes

Principal Investigator

Richard M. Goldberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Food and Drug Administration

Study ID:

EZN-2208-04

NCT ID:

NCT00931840

Start Date:

June 2009

Completion Date:

January 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • EZN-2208 (PEG-SN38)
  • Carcinoma
  • Colorectal Neoplasms

Name

Location

Location #033Tucson, Arizona  85724-5024
Location# 042Alhambra, California  91801
Location # 043Bakersfield, California  93309
Location# 044Fullerton, California  92835
Location# 019La Jolla, California  92093-0698
Location# 046Long Beach, California  90813
Location# 053Los Angeles, California  90095
Location# 051Northridge, California  91235
Location# 045Pomona, California  91767
Location # 049Santa Barbara, California  93105
Location # 048Santa Barbara,, California  93105
Location# 052Santa Maria, California  93454
Location #027Stanford, California  94305
Location# 003Newark, Delaware  19718
Location# 047Orlando, Florida  32804
Location# 022Port St. Lucie, Florida  34952
Location# 005Marietta, Georgia  30060
Location# 009Chicago, Illinois  60611-2927
Location #050Terre Haute, Indiana  47802
Location# 029Worcester, Massachusetts  01655
Location #031Lebanon, New Hampshire  03756
Location# 007Bronx, New York  10461
Location # 030Buffalo, New York  14263
Location# 002New York, New York  10016
Location# 035New York, New York  10003
Location# 001Chapel Hill, North Carolina  27514
Location# 020Goldsboro, North Carolina  27534
Location# 024Winston-Salem, North Carolina  27103
Location# 008Columbus, Ohio  43210
Location# 037Lancaster, Pennsylvania  17605
Location# 018Greenville, South Carolina  29615
Location# 004Memphis, Tennessee  38138
Location #038Houston, Texas  77584
Location# 011Lubbock, Texas  79410
Location# 021San Antonio, Texas  78229