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History of Changes for Study: NCT00403052
A Study of 1018 ISS Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
Latest version (submitted April 11, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 21, 2006 None (earliest Version on record)
2 January 23, 2007 Contacts/Locations and Study Status
3 July 5, 2007 Study Status, Contacts/Locations and Study Design
4 August 1, 2007 Arms and Interventions, Outcome Measures, Study Status, References and Oversight
5 November 1, 2007 Recruitment Status, Study Status and Contacts/Locations
6 June 16, 2014 Recruitment Status, Study Status, Eligibility, Sponsor/Collaborators and Study Identification
7 June 11, 2015 Study Status
8 August 19, 2015 Study Status
9 February 26, 2016 IPDSharing and Study Status
10 August 23, 2016 Study Status and IPDSharing
11 March 2, 2017 Study Status and IPDSharing
12 August 28, 2017 Study Design, Study Status and Contacts/Locations
13 February 27, 2018 Study Status and Contacts/Locations
14 February 12, 2019 Study Status
15 April 11, 2019 Study Status
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Study NCT00403052
Submitted Date:  November 21, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: DV2-ONC-01
Brief Title: A Study of 1018 ISS Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
Official Title: Phase 1 Study of the Combination of 1018 ISS, Irinotecan and Cetuximab in Patients With Metastatic Colorectal Cancer Previously Treated With a Fluoropyrimidine, Oxaliplatin or Irinotecan With or Without Bevacizumab
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2006
Overall Status: Recruiting
Study Start: November 2006
Primary Completion:
Study Completion: March 2008
First Submitted: November 21, 2006
First Submitted that
Met QC Criteria:
November 21, 2006
First Posted: November 23, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 21, 2006
Last Update Posted: November 23, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Dynavax Technologies Corporation
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The main objectives of this study are to establish a safe, tolerable and active dose of 1018 ISS administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer. Other objectives also include determining tumor response, time to disease progression, and overall survival in treated patients.
Detailed Description:

This is a Phase I, open-label study of escalating dose levels of 1018 ISS in combination with irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer. Approximately 15 patients will be treated. The objectives of this study are to establish a safe, tolerable, and active dose of 1018 ISS, determine tumor response, time to disease progression, and overall survival in treated patients.

The safety and tolerability of 1018 ISS will be evaluated by periodic laboratory assessments, physical examinations, and compilation of adverse events.

Once study patients have been consented, screened, and assigned to one of the dose levels of 1018 ISS, patients will receive two 4 week cycles of 1018 ISS therapy plus irinotecan every other week and cetuximab weekly. Irinotecan and cetuximab will continue thereafter until disease progression, unacceptable toxicity, or until the patient refuses treatment.

Open or close this module Conditions
Conditions: Colorectal Neoplasms
Keywords: colorectal
cancer
carcinoma
metastatic
colon
rectal
neoplasm
cetuximab
irinotecan
1018 ISS
combination therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 15
Open or close this module Arms and Interventions
Intervention Details:
Drug: 1018 ISS immunostimulatory oligonucleotide
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To establish the safety and tolerability of escalating dose levels of 1018 ISS administered with irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Signed, written, informed consent must be obtained from the patient or their legal representative before any study-specific procedures are performed
  • Confirmed diagnosis of adenocarcinoma of the colon or rectum not amenable to curative surgery
  • One or more prior systemic therapy regimens for metastatic cancer which must have included a fluoropyrimidine (5-FU by infusion or capecitabine), oxaliplatin or irinotecan with or without bevacizumab

Exclusion Criteria:

  • Clinically significant obstructive symptoms, intestinal bleeding, or chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
  • History of unstable or deteriorating cardiovascular or cerebrovascular disease within 3 months before the first dose of protocol therapy
  • Clinical evidence of brain metastases or central nervous system disease
  • Pregnant or lactating women
  • Serious medical or psychiatric illness
  • Malignancy other than colorectal carcinoma within the past 2 years, except curatively treated, superficial skin cancer or carcinoma in situ of the cervix
  • Patients who have been on any experimental study or anti-tumor therapy, received radiotherapy, or had prior surgery (except venous access device placement) within 28 days before the first dose of protocol therapy
Open or close this module Contacts/Locations
Locations: United States, California
Premiere Oncology
[Recruiting]
Santa Monica, California, United States, 90404
Contact:Contact: Ana M Silva, RN 310-633-8400 asilva@premiereoncology.com
Contact:Principal Investigator: Lee Rosen, MD
United States, District of Columbia
Lombardi Comprehensive Cancer Center, Georgetown University
[Not yet recruiting]
Washington, District of Columbia, United States, 20007
Contact:Contact: Lisa Ley, RN 202-687-6653 leyl@georgetown.edu
Contact:Principal Investigator: John Marshall, MD
United States, Maryland
Center for Cancer and Blood Disorders
[Recruiting]
Bethesda, Maryland, United States, 20817
Contact:Contact: Natalie Bonjiorno 202-784-4344 nbonjiorno@ccbdmd.com
Contact:Principal Investigator: Ralph Boccia, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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