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Phase II Trial of Cetuximab in Patients With Metastatic and/or Locally Advanced Soft Tissue and Bony Sarcomas

Phase 2
16 Years
Not Enrolling

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Trial Information

Phase II Trial of Cetuximab in Patients With Metastatic and/or Locally Advanced Soft Tissue and Bony Sarcomas

Sarcomas are mesenchymal malignancies that arise in the connective tissue throughout the
body and afflict approximately 11,000 people in the United States yearly. Sarcomas are
heterogeneous with well over 50 subtypes described. The peak incidence is subtype-specific
with certain sarcomas seen in children and young adults while other subtypes peak in late
middle-age, causing significant morbidity and mortality in young patients and productive

The precise etiology for most sarcomas remains unknown. External radiation therapy is an
established risk factor. Other risk factors include occupational exposures to certain
chemicals, lymphedema, and hereditary conditions such as neurofibromatosis and Li-Fraumeni
syndrome. Many sarcomas are associated with specific somatic genetic alterations. For
example, some specific subtypes are associated with gene translocations causing aberrant
fusion proteins including Ewing sarcoma (EWS-FLI-1), synovial sarcoma (SSX-SYT), alveolar
rhabdomyosarcoma (PAX3-FHKR), and myxoid liposarcomas (TLS-CHOP). These singular molecular
alterations imply that some sarcomas are cytogenetically simple and may be more appropriate
substrates for therapy targeted to a single molecular pathway.

Sarcomas are commonly present as an asymptomatic mass or with local symptoms in an extremity
or the retroperitoneum. Although tumor size, location, and histologic subtype have been
implicated as prognostic factors in sarcomas, histologic grade remains the most important
factor. Tumor grade is based on the degree of cellularity, differentiation, pleomorphism,
necrosis, and the number of mitoses. Approximately 50-60% of patients with high grade soft
tissue sarcoma will eventually have metastatic disease, as compared to 5-10% of patients
with low grade disease.

Sarcomas spread hematogenously with the most common site of spread being the lung, followed
by liver, bone, and brain. About 50% of patients with sarcoma eventually expire due to
locally advanced or metastatic disease with a median survival of 8-12 months.

Inclusion Criteria:

To be eligible for the study, patients must fulfill all of the following criteria:

1. Patients must have the ability to give informed consent and have signed an approved
informed consent form.

2. Patients must have a pathologic diagnosis of soft tissue sarcoma or bony sarcoma.

3. Patients with tumor tissue available for assessment of EGFR status performed by
immunohistochemistry (IHC).

4. Patients with Zubrod performance status 0-2.

5. Patients must be 16 years of age or older.

6. Patients, 16 years or older, must either be not of child bearing potential or have a
negative pregnancy test within 7 days of treatment. Patients are considered not of
child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are

7. If patients are childbearing or have child-fathering potential, they must use barrier
contraception during intercourse while being treated on this study.

8. Bone marrow function: absolute neutrophil count (ANC) 1,000/ul; platelets 75,000/l.

9. Renal function: creatinine 2.0 x institutional upper limit of normal (ULN).

10. Hepatic function: bilirubin 2.5 x ULN; AST 5.0 x ULN.

11. Patients must have received at least one systemic chemotherapy treatment or else
refuse to be treated with cytotoxic therapy.

12. Twenty-eight days or more should have elapsed since the patient has received any
prior systemic therapy.

13. Patients must have documented symptomatic or radiologic progression to their
preceding therapy.

14. For patients treated with prior radiation, 21 days or more should have elapsed since
the administration of the last fraction of radiation therapy and patients must have
recovered from all associated toxicities.

15. Patients must have measurable disease. The measurable lesion should be outside
previously irradiated fields or have documented progression at least 6 weeks after
completion of radiation.

Exclusion Criteria:

Any of the following criteria will make the patient ineligible to participate in this

1. Acute hepatitis or known HIV.

2. Active or uncontrolled infection.

3. Significant history of uncontrolled cardiac disease i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure, and cardiomyopathy with decreased ejection fraction.

4. Prior therapy which specifically and directly targets the EGFR pathway.

5. Prior severe infusion reaction to a monoclonal antibody.

6. Any concurrent chemotherapy not indicated in the study protocol or any other
investigational agent(s).

7. Other active systemic malignancy within the past year.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Sarcoma Who Are Tumor Progression Free and Alive at Four Months From Start of Treatment With Single-agent Cetuximab.

Outcome Description:

Time of cetuximab administration to clinically documented progression of disease or death assessed for four months after starting cetuximab therapy

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Rashmi Chugh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2004-078



Start Date:

June 2005

Completion Date:

December 2009

Related Keywords:

  • Sarcoma
  • Unresectable/metastatic high grade soft tissue bony sarcoma
  • Sarcoma



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752