Trial of Cetuximab in Patients With Metastatic and/or Locally Advanced Soft Tissue and Bony Sarcomas
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: Cetuximab; Cetuximab
Intervention description: The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes.; Cetuximab 400 mg/m2 over 120 min IV initial does followed by weekly Cetuximab 250 mg/m2 over 60 min
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Unresectable/metastatic high grade soft tissue bony sarcoma

Summary:

      The purpose of this study is to explore how this cancer is affected by a new medication,
      cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor
      receptor), that is found in some types of cancer. Studies have shown that this drug can be
      beneficial in patients with colon cancer and has been approved by the US Food and Drug
      Administration (FDA) for this purpose. The researchers are conducting a study to see if it is
      beneficial in patients with sarcoma.
    

Eligibility criteria:

        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
             postmenopausal.

          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
        study:

          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.