Study of IMC-A12, Alone or in Combination With Cetuximab, in Patients With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00617734
First received: January 30, 2008
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase survival in patients with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.


Condition Intervention Phase
Head and Neck Cancer
Biological: IMC-A12 (cixutumumab)
Biological: cetuximab (Erbitux ®)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Evaluation every 8 weeks ] [ Designated as safety issue: No ]
    Patient evaluation every 8 weeks until patient has Progression of Disease (PD) or dies


Secondary Outcome Measures:
  • Objective response rates (ORR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation every 6 month for PD or dies

  • 6-month PFS rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    6 Month Progression Free Survival (PFS) rate will be Determined every

  • Overall survival rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients will be examined every 6 months to determine overall survival rate

  • Duration of response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Duration of response will be determined every 6 months.

  • Summary Listing of Participants Reporting Treatment-Emergent Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety and AE-from 1st treatment every 2 weeks until 30 days post last treatment (therapy related AE followed until resolution or deemed irreversible

  • Blood and tissue biomarkers and the development of serum antibodies against IMC-A12 and cetuximab [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Immunogenicity-Prior to 1st infusion, prior to Cycle 3 infusion, prior to cycle 5 infusion If infusion reaction to A12- closest to onset, at resolution and 30 days after event.


Enrollment: 91
Study Start Date: March 2008
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-A12 (cixutumumab) Biological: IMC-A12 (cixutumumab)
IMC-A12 10 mg/kg over one hour every two weeks. A cycle is defined as four weeks of therapy. Patients will continue on study until evidence of progressive disease, or unacceptable toxicity develops.
Other Name: Cixutumumab
Experimental: IMC-A12 (cixutumumab) + cetuximab Biological: IMC-A12 (cixutumumab)
IMC-A12 10 mg/kg over one hour every two weeks. A cycle is defined as four weeks of therapy. Patients will continue on study until evidence of progressive disease, or unacceptable toxicity develops.
Other Name: Cixutumumab
Biological: cetuximab (Erbitux ®)
IMC-A12 10 mg/kg over one hour followed by cetuximab 500 mg/m2 over 2 hours. This sequence will be repeated every 2 weeks. Patients will continue on study until evidence of disease progressive disease or unacceptable toxicity develops.
Other Name: Erbitux®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617734

Locations
United States, California
ImClone Investigational Site
Orange, California, United States, 92868
United States, Florida
ImClone Investigational Site
Miami, Florida, United States, 33136
ImClone Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
ImClone Investigational Site
Atlanta, Georgia, United States, 30322
United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60637
United States, Maryland
ImClone Investigational Site
Baltimore, Maryland, United States, 21231
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02115
United States, Minnesota
ImClone Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
ImClone Investigational Site
Bronx, New York, United States, 10467
ImClone Investigational Site
New York, New York, United States, 10003
United States, Pennsylvania
ImClone Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
ImClone Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
ImClone Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
ImClone Investigational Site
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
ImClone LLC
Investigators
Study Director: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

No publications provided

Responsible Party: ImClone LLC
ClinicalTrials.gov Identifier: NCT00617734     History of Changes
Other Study ID Numbers: 13913, CP13-0706, CP02-0758, 15A-IE-JAEB
Study First Received: January 30, 2008
Last Updated: August 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
Squamous Cell Carcinoma in Head and Neck
Prior Platinum-based chemotherapy
Cetuximab
Erbitux
IMC-A12

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014