Status:
COMPLETED
Study of IMC-11F8 in Participants With Colorectal Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).
Detailed Description
The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination wi...
Eligibility Criteria
Inclusion
- Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC
- Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum
- At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area
- Age ≥18 years
- Life expectancy of ≥6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at study entry
- Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5 x 10\^9 liter (L), hemoglobin ≥10 grams per deciliter (g/dL), and platelets ≥100 x 10\^9/L
- Adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per deciliter (mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and alkaline phosphatase (AP) ≤2.5 x ULN (or 5.0 x ULN in the case of liver metastases)
- Adequate renal function as defined by a serum creatinine ≤1.5 x ULN, creatinine clearance ≥ 60 milliliters per minute (mL/min), or serum albumin ≥lower limit of normal (LLN)
- Participant's relevant toxicities/effects of prior therapy \[surgery/radiation therapy (RT)\] must have recovered to a stable or chronic level
- Participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Participants must notify the principal investigator if they themselves or their partner becomes pregnant.
- Participant has provided signed Informed Consent
Exclusion
- Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC.
- Has received prior radiotherapy to \>25% of bone marrow
- Has documented and/or symptomatic brain metastases
- Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry
- Has received previous therapy with monoclonal antibodies
- Has received previous therapy with any agent that targets the EGFR
- Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study.
- On chronic non-topical corticosteroid treatment for \>6 months at doses \>10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study
- Has a known dihydropyrimidine dehydrogenase deficiency
- Has a known allergy to any of the treatment components
- Has an acute or subacute intestinal occlusion
- Has peripheral neuropathy ≥Grade 2
- Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
- If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding
- Has received a prior autologous or allogeneic organ or tissue transplantation
- Has interstitial pneumonia or interstitial fibrosis of the lung
- Has pleural effusion or ascites that causes ≥Grade 2 dyspnea
- Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00835185
Start Date
August 1 2007
End Date
October 1 2010
Last Update
January 29 2016
Active Locations (5)
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1
ImClone Investigational Site
Brussels, Belgium, 1000
2
ImClone Investigational Site
Haine-Saint-Paul, Belgium, 7100
3
ImClone Investigational Site
Barcelona, Spain, 08035
4
ImClone Investigational Site
Madrid, Spain, 28040