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

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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 Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.

Key facts

Study ID

NCT00617734

Run by

Eli Lilly and Company

People needed

97

Starts

2008-03-01

Expected to finish

2012-07-01

Last updated by the study team

2018-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ImClone Investigational Site — Orange, California, United States
• ImClone Investigational Site — Miami, Florida, United States
• ImClone Investigational Site — Orlando, Florida, United States
• ImClone Investigational Site — Atlanta, Georgia, United States
• ImClone Investigational Site — Chicago, Illinois, United States
• ImClone Investigational Site — Baltimore, Maryland, United States
• ImClone Investigational Site — Boston, Massachusetts, United States
• ImClone Investigational Site — Rochester, Minnesota, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — The Bronx, New York, United States
• ImClone Investigational Site — Pittsburgh, Pennsylvania, United States
• ImClone Investigational Site — Nashville, Tennessee, United States
• ImClone Investigational Site — Houston, Texas, United States
• ImClone Investigational Site — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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