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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


The routine cancer treatments for Squamous Cell Carcinoma Head and Neck Cancer have improved
but still leave a percentage of patients with incurable disease. New alternatives for
patients whose disease is refractory to existing therapies is needed.

IMC-A12 is a monoclonal antibody which binds to special receptors known as IGF-1R. 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 evaluation the effects of IMC-A12 by itself or with
Cetuximab (Erbitux®) in patients 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 patient is receiving
treatment.


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 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-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 mg/dL or below the 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 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. Patients 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Patient evaluation every 8 weeks until patient has Progression of Disease (PD) or dies

Outcome Time Frame:

Evaluation every 8 weeks

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13913

NCT ID:

NCT00617734

Start Date:

March 2008

Completion Date:

July 2012

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Carcinoma in Head and Neck
  • Prior Platinum-based chemotherapy
  • Cetuximab
  • Erbitux
  • IMC-A12
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteDecatur, Illinois  62526
ImClone Investigational SiteBaltimore, Maryland  21204
ImClone Investigational SiteMinneapolis, Minnesota  55416
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteNorfolk, Virginia  23502
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteBoston, Massachusetts  02135