Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer
NCT ID: NCT00719199
Last Updated: 2013-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
21 participants
INTERVENTIONAL
2009-01-31
2011-08-31
Brief Summary
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There are two distinct parts in this study:
* Part 1: Dose escalation from IMO-2055
* Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored
Detailed Description
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* Part 2: A final cohort of 12 patients (Cohort 6) will be enrolled simultaneously to explore tolerability and pharmacodynamics in patients treated with the RP2D of IMO-2055 in combination with FOLFIRI with cetuximab.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
IMO 2055 is a novel phosphorothioate oligodeoxynucleotide that is an agonist of Toll-like Receptor 9 (TLR9).
IMO-2055
SC weekly injections
Cetuximab
given weekly through intravenous administration. Cycle 1 Day 1 dose given at 400mg/m2, all subsequent doses given at 250 mg/m2.
FOLFIRI
Given day 1 of each cycle
Interventions
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IMO-2055
SC weekly injections
Cetuximab
given weekly through intravenous administration. Cycle 1 Day 1 dose given at 400mg/m2, all subsequent doses given at 250 mg/m2.
FOLFIRI
Given day 1 of each cycle
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients aged ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed adenocarcinoma of the colon or rectum with advanced or metastatic disease.
5. Patients whose disease has recurred or progressed during or after completion of at least one (1) standard regimen of cytotoxic agents. Patients may have had any number of prior regimens as long as the other entry criteria are met. Preferred patients are those who have progressed on first line FOLFIRI or FOLFOX with or without bevacizumab. Patients may have had prior exposure to monoclonal antibodies such as cetuximab, bevacizumab or panitumumab.
6. All clinically significant adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to CTCAE v3.0 grade ≤ 1. Neuropathy of CTCAE v3.0 grade ≤ 2 will be allowed but the neuropathy should be closely monitored throughout the trial.
7. A minimum of 4 weeks must occur between last receipt of chemotherapy, biotherapy, radiotherapy, or major surgery and registration.
8. Be willing and able to comply with the protocol for the duration of the study.
9. If prior malignancy was diagnosed, other than colorectal, no evidence of disease from that cancer, off all therapy for that cancer and recovered to grade 1 or less toxicity from prior treatment.
Exclusion Criteria
Disease
1. Known central nervous system (CNS) metastases unless controlled for ≥ 4 months without the use of steroids.
2. Patients who are candidates for neoadjuvant "conversion" therapy followed by curative surgery.
Prior Treatments
3. Prior pelvic irradiation.
4. Administration of any investigational agent (therapeutic or diagnostic), within 4 weeks prior to first study dosing.
5. Patients with a prior history of cetuximab hypersensitivity may be admitted to Part 1 of the study only.
Other Concomitant Medications
6. Chronic oral or intravenous corticosteroids. (Note: Doses ≤ 5 mg/day of prednisone or equivalent are permitted. Topical, inhaled and intra-articular corticosteroids are allowed.)
7. Therapeutic anticoagulation (warfarin \> 1 mg/day or heparin). Low-dose warfarin for port prophylaxis and low-molecular weight heparin at therapeutic doses are allowed.
Laboratory
8. The following laboratory results:
* Hemoglobin \< 9.0 g/dL Absolute neutrophil count \< 1.5 x 109/L Platelet count \< 100 x 109/L
* Total bilirubin \> 1.5 x upper limit of normal (ULN)
* ALT or AST \> 2.5 x ULN (\> 5 x ULN if liver metastases present)
* Alkaline phosphatase \> 2.5 x ULN (\> 5 x ULN if liver metastases present, or \> 10 x ULN in case of the presence of bone metastases)
* Serum creatinine \> 1.5 x ULN
* Albumin \< 2.5 g/dL Other Conditions or Procedures
9. Grade 3 or 4 non-hematological toxicity or febrile neutropenia related to previous irinotecan-based regimens.
10. Homozygous for the UGT1A1\*28 allele.
11. Known hypersensitivity to murine proteins or oligonucleotides.
12. Pregnant or breast-feeding women.
13. Women of childbearing potential with either positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
14. Men or women of childbearing potential who refuse or who are unable to use an acceptable means of contraception during the study.
15. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance.
16. Pre existing autoimmune or antibody-mediated diseases, including, but not limited to, the following: organ allografts, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome and autoimmune thrombocytopenia, known Gilbert's syndrome.
17. Signs/symptoms of bowel obstruction or pseudo-obstruction or history of inflammatory bowel disease.
18. Clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
19. Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
20. Serious uncontrolled concomitant disease, intercurrent infections, or other known medical conditions that in the opinion of the Investigator puts the patient at increased risk for significant toxicities from treatment, such as hypertension, uncontrolled by medication, chronic hepatitis (viral or other) or cirrhosis, known human immunodeficiency virus (HIV) infection, or uncontrolled diabetes.
21. Legal incapacity or limited legal capacity.
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Phil Breitfeld, MD
Role: STUDY_DIRECTOR
EMD Serono
Locations
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Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Cancer Therapy & Research Center
San Antonio, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
Countries
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References
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Chan E, Kwak EL, Hwang J, Heiskala M, de La Bourdonnaye G, Mita M. Open-label phase 1b study of FOLFIRI plus cetuximab plus IMO-2055 in patients with colorectal cancer who have progressed following chemotherapy for advanced or metastatic disease. Cancer Chemother Pharmacol. 2015 Apr;75(4):701-9. doi: 10.1007/s00280-015-2682-2. Epub 2015 Jan 28.
Other Identifiers
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EMR200068_210
Identifier Type: -
Identifier Source: secondary_id
IMO-2055-210
Identifier Type: -
Identifier Source: org_study_id