Clinical trial NCT00617734: 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
Official title: A Randomized Phase 2 Open-Label Study of IMC-A12, as a Single Agent or in Combination With Cetuximab, in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Disease Progression on Prior Platinum-Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Squamous Cell Carcinoma in Head and Neck
Prior Platinum-based chemotherapy
Cetuximab
Erbitux
IMC-A12
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 whose disease is refractory to existing therapies is needed.

IMC-A12 is a monoclonal antibody which binds to special receptors known as insulin-like growth factor-I receptor (IGF-IR). This binding action has been shown to inhibit the growth of a variety of human tumor cell lines.

The purpose of this study is to evaluate the effects of IMC-A12 by itself or with Cetuximab (Erbitux®) in participants with Squamous Cell Carcinoma Head and Neck Cancer that has spread to other parts of the body, and to determine how long the drug remains in the body. The study will also look at what side effects IMC-A12 may cause when a participant is receiving treatment.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to measured PD (up to 27.66 months)
Secondary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
timeFrame: Baseline to measured PD (up to 27.66 months)
measure: Percentage of Participants With PFS at 6 Months
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: Baseline to date of death from any cause (up to 29.63 months)
measure: Duration of Response
timeFrame: Date of first response to the date of PD or death due to any cause (up to 23.98 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
timeFrame: Baseline through study completion (up to 29.63 months)
measure: Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab
timeFrame: Biomarkers [pre-dose, Cycle 1 (Day 15), (Cycle 2 (Day 1), and end of treatment]; Immunogenicity [pre-dose, prior to first infusion for Cycle 3, Cycle 5, and 30-day safety follow-up]
Other outcomes:
Locations:
city: Orange
country: United States
facility: ImClone Investigational Site
state: California
city: Miami
country: United States
facility: ImClone Investigational Site
state: Florida
city: Orlando
country: United States
facility: ImClone Investigational Site
state: Florida
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Chicago
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: ImClone Investigational Site
state: Maryland
city: Boston
country: United States
facility: ImClone Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: ImClone Investigational Site
state: Minnesota
city: Bronx
country: United States
facility: ImClone Investigational Site
state: New York
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: Pittsburgh
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Houston
country: United States
facility: ImClone Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: ImClone Investigational Site
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: