Status:
TERMINATED
A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
NSABP Foundation Inc
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC).
Detailed Description
The purpose of this study is to determine the value of adding IMC-A12 to irinotecan + cetuximab in improving progression-free survival (PFS) at 18 weeks from the date of randomization for participants...
Eligibility Criteria
Inclusion
- Must consent to be in the study and must have signed and dated Institutional Review Board (IRB)-approved consent forms conforming to federal and institutional guidelines for the pre-entry tumor sample submission for central K-RAS testing and for the study treatment
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Must have metastatic CRC
- The CRC tumor or metastatic tumor must be v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog gene (K-RAS) wild-type as determined by central testing
- Must be documented disease progression during first-line therapy containing both oxaliplatin and bevacizumab
- Most recent treatment regimen must have ended ≥21 days prior to randomization, and clinically significant side effects associated with previous therapy must have resolved to ≤Grade 1 with the exception of neuropathy which must have resolved to ≤Grade 2
- Imaging of the chest, abdomen and pelvis with computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 3 weeks prior to randomization
- Must have measurable disease, defined as at least 1 lesion outside a previous radiation therapy (RT) field that can be accurately measured in at least 1 dimension as ≥20 millimeters (mm) with conventional techniques or as ≥10mm with 5mm cuts using a spiral CT scan
- Evidence of adequate bone marrow function: absolute neutrophil (ANC) ≥1200 cubed millimeters (mm³), hemoglobin ≥9 grams per deciliter (g/dL), platelets ≥100,000 mm³
- Evidence of adequate hepatic function. If no liver metastases: aspartate aminotransferase (AST) ≤2.5 times (x) upper limit of normal (ULN), total bilirubin ≤1.5 x ULN for the lab. In the presence of liver metastases: AST ≤5.0 x ULN, total bilirubin ≤1.5 x ULN for the lab
- Serum creatinine must be ≤1.5 x ULN for the lab
- Must have a fasting blood glucose \<126 milligrams/deciliter (mg/dL). Fasting is defined as no caloric intake for at least 8 hours
Exclusion
- Life expectancy less than 12 weeks
- Diagnosis of anal or small bowel carcinoma
- Tumor that is considered by the surgeon to be amenable to complete resection
- Previous RT to \>25% of bone marrow
- RT to sites of measurable disease chosen as target lesions
- Radiological evidence and/or clinical signs or symptoms of central nervous system (CNS) metastases
- Any of the following conditions and events: uncontrolled hypertension, defined as systolic blood pressure (BP) \>150 millimeters of mercury (mmHg) or diastolic BP \>100 mmHg with or without antihypertensive medication (participants with hypertension that is well-controlled on medication are eligible); unstable angina within 6 months before randomization; New York Heart Association (NYHA) Class III or IV cardiac disease; myocardial infarction (MI) within 6 months before randomization; symptomatic arrhythmia; CNS cerebrovascular ischemia \[transient ischemic attack (TIA) or stroke\] within 6 months before randomization
- Other malignancies unless the participant is considered to be disease-free and has completed therapy for the malignancy ≥12 months prior to randomization. Participants with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin
- Serious or non-healing wound, skin ulcers, or bone fracture
- Any significant bleeding unless the source of bleeding has been resected
- History of bleeding diathesis or coagulopathy (participants on stable anticoagulant therapy are eligible)
- Any evidence of active infection
- Active inflammatory bowel disease
- Grade 3 or 4 diabetes mellitus as defined by National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 pancreatic endocrine: glucose intolerance (participants with diabetes controlled with diet and/or oral medications are eligible)
- Symptomatic interstitial pneumonitis or definitive evidence of interstitial pneumonitis described on CT scan or chest x-ray in asymptomatic participants
- Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
- Previous hypersensitivity reaction to monoclonal antibodies
- Previous treatment with irinotecan, cetuximab, or any agent specifically targeting insulin-like growth factor (IGF) receptors
- Treatment with an investigational drug within 30 days prior to randomization
- Pregnancy or lactation at the time of participant entry
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00845039
Start Date
May 1 2009
End Date
February 1 2011
Last Update
July 2 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
ImClone Investigational Site
Vallejo, California, United States, 94589
2
ImClone Investigational Site
Greenville, North Carolina, United States, 27834
3
ImClone Investigational Site
Scranton, Pennsylvania, United States, 18510