Return to List

Study Summary
No. 2007-0636:.......Head And Neck......Bonnie S. Glisson......Thoracic and Head and Neck Med
.
Study Summary Title
Study Summary
Number:
2007-0636
Study 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
.
Physician New Patient Referral
Name:Bonnie S. GlissonPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Thoracic and Head and Neck MedReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6363
Contact us about clinical trials
.
General Information
Disease Group:Head And NeckSupported By:ImClone Systems Incorporated
Phase of Study:Phase IIReturn
Visit:
A tx cycle is defined as 4 wks, w/ radiological evaluation every 2 cycles (ie,
every
8 wks). There is no interruption between tx cycles. Pts will be treated until
evidence of disease
progression, toxicity requiring cessation, or withdrawal of consent.
Treatment
Agents:
Cetuximab
IMC-A12
Home Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn if IMC-A12 (cixutumumab)
given with or without cetuximab can help to control head and neck cancer that
has spread to other parts of the body or has not responded to treatment. The
safety of these drugs will also be studied.
.
Study Objectives / Outcomes
Primary Objective:

To assess median progression-free survival (PFS) in patients with recurrent or metastatic squamous cell
carcinoma of the head and neck (SCCHN) who have experienced disease progression on at least one
prior platinum-containing chemotherapeutic regimen, when treated with IMC-A12 monotherapy or
IMC-A12 and cetuximab combination therapy.

Secondary Objective(s):
  • To determine the objective response rate (ORR)
  • To determine the 6-month progression-free survival rates
  • To determine the overall survival rates
  • To determine the duration of response
  • To evaluate the safety, tolerability, and adverse event profiles of these therapeutic regimens in
the treatment of recurrent or metastatic SCCHN
  • To assess blood and tissue biomarkers and the development of serum antibodies against
IMC-A12 and cetuximab
.
Study Status Information
Study Activation / Registration Date:02/13/2008
IRB Review and Approval Date:02/13/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:90
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) The patient has histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical imaging studies.

2) The patient has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded), with minimum lesion size >/= 2 cm on conventional measurement techniques or >/= 1 cm on spiral computed tomography (CT) scan.

3) The patient has 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).

4) If the patient has received prior treatment with anti-EGFR therapy, the time to recurrence from last exposure to anti-EGFR therapy is > 90 days.

5) The patient is age >/=18 years.

6) The patient has a life expectancy of > 3 months.

7) The patient has an Eastern Cooperative Oncology Group performance status of 0-2.

8) The patient has adequate hematologic function as defined by absolute neutrophil count >/= 1500/uL, hemoglobin >/= 9 g/dL, and platelet count >/=100,000/uL.

9) The patient has adequate hepatic function as defined by a total bilirubin </= 1.5 x the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) </= 3 x the ULN (or </= 5 x the ULN in the presence of known liver metastases).

10) The patient has either adequate coagulation function as defined by international normalized ratio (INR)</= 1.5 and partial thromboplastin time (PTT) no more than 5 seconds above the ULN or is on a stable dose of an anticoagulant.

11) The patient has adequate renal function as defined by serum creatinine </=1.5 x the institutional ULN or creatinine clearance >/= 60 mL/min for patients with creatinine levels above the ULN.

12) The patient has fasting serum glucose <120 mg/dL or below the ULN.

13) Because the teratogenicity of the study medications is uncertain, 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.

14) The patient has the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:1) The patient has not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have recovered to NCI-CTCAE Version 3.0 grade </= 2.

2) The patient is receiving any other investigational agent(s).

3) The patient has a history of treatment with other agents targeting the IGFR.

4) The patient is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy. Patients receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.

5) The patient has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or IMC-A12.

6) The patient 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.

7) The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

8) The patient is pregnant or breastfeeding.

9) The patient is known to be positive for infection with the human immunodeficiency virus.

10) The patient is receiving therapy with immunosuppressive agents.

11) The patient has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor curatively resected treated with no known active disease present and no treatment administered for the last 3 years.

.
Links
Registration Number: NCT00617734
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center