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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Enzon Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00931840
First received: June 30, 2009
Last updated: September 19, 2011
Last verified: September 2011

June 30, 2009
September 19, 2011
June 2009
October 2011   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00931840 on ClinicalTrials.gov Archive Site
Progression Free Survival (PFS) [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
Drug: 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 Names:
  • Irinotecan, (CPT 11),(Camptosar®)
  • Erbitux (cetuximab)
  • Experimental: 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.

    Intervention: Drug: EZN-2208, Cetuximab and Irinotecan
  • Experimental: 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.
    Intervention: Drug: EZN-2208, Cetuximab and Irinotecan
  • Active Comparator: 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.
    Intervention: Drug: EZN-2208, Cetuximab and Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
January 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands,   Canada,   United Kingdom,   Israel
 
NCT00931840
EZN-2208-04
Yes
Enzon Pharmaceuticals, Inc.
Enzon Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Richard M. Goldberg, MD University of North Carolina, Chapel Hill
Enzon Pharmaceuticals, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP