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 - Full Text View

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 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:

Genetics Home Reference related topics: head and neck squamous cell carcinoma

Drug Information available for: Cetuximab

U.S. FDA Resources

Further study details as provided by ImClone LLC:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Evaluation every 8 weeks ]
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 ]
Evaluation every 6 month for PD or dies
6-month PFS rates [ Time Frame: 6 months ]
6 Month Progression Free Survival (PFS) rate will be Determined every
Overall survival rates [ Time Frame: 6 months ]
Patients will be examined every 6 months to determine overall survival rate
Duration of response [ Time Frame: 6 months ]
Duration of response will be determined every 6 months.
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events [ Time Frame: 6 months ]
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 ]
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®

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 (Adult, Senior)
Sexes Eligible for Study:	All
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


Responsible Party:	ImClone LLC
ClinicalTrials.gov Identifier:	NCT00617734 History of Changes
Other Study ID Numbers:	13913 CP13-0706 ( Other Identifier: ImClone, LLC ) CP02-0758 ( Other Identifier: ImClone, LLC ) 15A-IE-JAEB ( Other Identifier: Eli Lilly and Company )
Study First Received:	January 30, 2008
Last Updated:	August 3, 2012

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

ClinicalTrials.gov processed this record on July 17, 2017