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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; ImClone LLC
• Treatments: Cetuximab

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.