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Metastatic Colorectal CancerPhase 2NCT00931840

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

A Phase 2 study testing EZN-2208, Cetuximab and Irinotecan in people with Metastatic Colorectal Cancer, run by Enzon Pharmaceuticals, Inc. at 60 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
EZN-2208, Cetuximab and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
60 sitesin 5 countries
Study dates
Jun 2009to Jan 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

60 sites in 5 countries.

60 sites in 5 countries

United States35 sites

  • Location# 042

    Alhambra, California, 91801

  • Location # 043

    Bakersfield, California, 93309

  • Location # 030

    Buffalo, New York, 14263

  • Location# 001

    Chapel Hill, North Carolina, 27514

  • Location# 009

    Chicago, Illinois, 60611-2927

  • Location# 008

    Columbus, Ohio, 43210

  • Location# 044

    Fullerton, California, 92835

  • Location# 020

    Goldsboro, North Carolina, 27534

  • Location# 018

    Greenville, South Carolina, 29615

  • Location #038

    Houston, Texas, 77584

  • Location# 019

    La Jolla, California, 92093-0698

  • Location# 037

    Lancaster, Pennsylvania, 17605

  • Location #031

    Lebanon, New Hampshire, 03756

  • Location# 046

    Long Beach, California, 90813

  • Location# 053

    Los Angeles, California, 90095

  • Location# 011

    Lubbock, Texas, 79410

  • Location# 005

    Marietta, Georgia, 30060

  • Location# 004

    Memphis, Tennessee, 38138

  • Location# 035

    New York, New York, 10003

  • Location# 002

    New York, New York, 10016

  • Location# 003

    Newark, Delaware, 19718

  • Location# 051

    Northridge, California, 91235

  • Location# 047

    Orlando, Florida, 32804

  • Location# 045

    Pomona, California, 91767

  • Location# 022

    Port Saint Lucie, Florida, 34952

  • Location# 021

    San Antonio, Texas, 78229

  • Location # 048

    Santa Barbara, California, 93105

  • Location # 049

    Santa Barbara, California, 93105

  • Location# 052

    Santa Maria, California, 93454

  • Location #027

    Stanford, California, 94305

  • Location #050

    Terre Haute, Indiana, 47802

  • Location# 007

    The Bronx, New York, 10461

  • Location #033

    Tucson, Arizona, 85724-5024

  • Location# 024

    Winston-Salem, North Carolina, 27103

  • Location# 029

    Worcester, Massachusetts, 01655

Other trials in United States

United Kingdom10 sites

  • Location #065

    Dorchester, Dorset, DT1 2JY

  • Location# 056

    Edinburgh, Scotland, EH4 2XU

  • Location# 062

    Glasgow, Scotland, G12 0YN

  • Location# 063

    Leeds, West Yorkshire, LS9 7TF

  • Location # 083

    London, England, W8 8RF

  • Location# 057

    London, Greater London, SE1 7EH

  • Location# 054-2

    London, Greater London, SW3 6JJ

  • Location #061

    London, Greater London, W12 0HS

  • Location# 064

    Manchester, Greater Manchester, M20 4BX

  • Location# 054

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Israel8 sites

  • Location# 068

    Be’er Ya‘aqov, 70300

  • Location# 072

    Beersheba, South District, 84101

  • Location# 067

    Haifa, 31096

  • Location# 073

    Jerusalem District, 91120

  • Location# 071

    Kfar Saba, Sharon, 44281

  • Location# 070

    Tel Aviv, 64239

  • Location# 069

    Tel HaShomer, 52621

  • Location# 066

    Tel-Aviv, Central District, 69710

Other trials in Israel

Canada5 sites

  • Location# 077

    Montreal, Quebec, H2W 1S6

  • Location# 074

    Montreal, Quebec, H3T 1E2

  • Location# 076

    Ottawa, Ontario, K1H 8L6

  • Location# 055

    Rimouski, Quebec, G5L 5T1

  • Location # 079

    Toronto, Ontario, M4C3E7

Other trials in Canada

Netherlands2 sites

  • Location# 041

    Leiden, NL, 2333ZA

  • Location # 040

    Rotterdam, The Netherlands

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
EZN-2208, Cetuximab and Irinotecan
Keywords
EZN-2208 (PEG-SN38)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EZN-2208, Cetuximab and IrinotecanDrug

    Also called Irinotecan, (CPT 11),(Camptosar®), Erbitux (cetuximab)

    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).

Study groups in NCT00931840
Study groupRoleWhat they receive
EZN-2208ExperimentalEZN-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.
Receives: Drug: EZN-2208, Cetuximab and Irinotecan
Cetuximab + EZN-2208ExperimentalCetuximab 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.
Receives: Drug: EZN-2208, Cetuximab and Irinotecan
Irinotecan + cetuximabActive comparatorCetuximab 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.
Receives: Drug: EZN-2208, Cetuximab and Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    Measured: 2011

Secondary outcomes (1)

  1. Progression Free Survival (PFS)

    Measured: 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionOct 2011 (estimated)
  4. Study completionJan 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931840
Sponsor's protocol ID
EZN-2208-04
Status last verified
Sep 2011
First submitted
30 Jun 2009
Last updated
20 Sep 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EZN-2208, Cetuximab and Irinotecan in people with Metastatic Colorectal Cancer, run by Enzon Pharmaceuticals, Inc. at 60 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, United Kingdom, Israel, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 2011). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00931840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.

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