Status:
COMPLETED
Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck
Lead Sponsor:
Eli Lilly and Company
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Ne...
Detailed Description
The routine cancer treatments for Squamous Cell Carcinoma Head and Neck Cancer have improved but still leave a percentage of participants with incurable disease. New alternatives for participants whos...
Eligibility Criteria
Inclusion
- Histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical imaging studies
- Measurable disease, lesion size ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
- Clinical documentation of disease progression during treatment with or within 90 days after receiving the last cycle of platinum-based chemotherapy (with or without radiation therapy)
- If prior treatment with anti-epidermal growth factor receptor (EGFR) therapy, the time to recurrence from last exposure to anti-EGFR therapy is \> 90 days
- Adequate hematologic function
- Adequate hepatic function
- Adequate coagulation function or is on a stable dose of an anticoagulant.
- Adequate renal function
- Fasting serum glucose \<120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion
- Not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, must have recovered to grade ≤ 2
- Is receiving any other investigational agent(s)
- History of treatment with other agents targeting the insulin-like growth factor receptor (IGFR)
- Is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or IMC-A12
- Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting \< 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
- Pregnant or breastfeeding
- Is receiving therapy with immunosuppressive agents
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00617734
Start Date
March 1 2008
End Date
July 1 2012
Last Update
April 17 2018
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
ImClone Investigational Site
Orange, California, United States, 92868
2
ImClone Investigational Site
Miami, Florida, United States, 33136
3
ImClone Investigational Site
Orlando, Florida, United States, 32806
4
ImClone Investigational Site
Atlanta, Georgia, United States, 30322