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

NCT00148109 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2004-078Legacy IRB #2005-0072
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma

Keywords

Unresectable/metastatic high grade soft tissue bony sarcoma

Outcome Measures

Primary Outcomes (1)

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

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

  4 months

Secondary Outcomes (2)

• Progression Free Survival.

  survival

• Overall Survival

  months

Study Arms (2)

EGFR positive

ACTIVE COMPARATOR

The EGFR positive group will be conducted in a 2-stage minimax trial design to determine the rate of four-month progression free survival in this patient population treated with cetuximab

Drug: Cetuximab

EGFR Negative

ACTIVE COMPARATOR

The EGFR negative group will help us explore the possibility of benefit of cetuximab in a patient whose tumor does not express or minimally expresses EGFR. If benefit in progression-free survival or in another surrogate such as tumor response or a molecular event is seen in this group it would provide rationale to study this group further in subsequent trials

Drug: Cetuximab

Interventions

Cetuximab DRUG

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.

EGFR positive

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the study, patients must fulfill all of the following criteria:
• Patients must have the ability to give informed consent and have signed an approved informed consent form.
• Patients must have a pathologic diagnosis of soft tissue sarcoma or bony sarcoma.
• Patients with tumor tissue available for assessment of EGFR status performed by immunohistochemistry (IHC).
• Patients with Zubrod performance status 0-2.
• Patients must be 16 years of age or older.
• 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.
• If patients are childbearing or have child-fathering potential, they must use barrier contraception during intercourse while being treated on this study.
• Bone marrow function: absolute neutrophil count (ANC) 1,000/ul; platelets 75,000/l.
• Renal function: creatinine 2.0 x institutional upper limit of normal (ULN).
• Hepatic function: bilirubin 2.5 x ULN; AST 5.0 x ULN.
• Patients must have received at least one systemic chemotherapy treatment or else refuse to be treated with cytotoxic therapy.
• Twenty-eight days or more should have elapsed since the patient has received any prior systemic therapy.
• Patients must have documented symptomatic or radiologic progression to their preceding therapy.
• 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.

You may not qualify if:

• Any of the following criteria will make the patient ineligible to participate in this study:
• Acute hepatitis or known HIV.
• Active or uncontrolled infection.
• 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.
• Prior therapy which specifically and directly targets the EGFR pathway.
• Prior severe infusion reaction to a monoclonal antibody.
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
• Other active systemic malignancy within the past year.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Bristol-Myers Squibb: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

accrual to EGFR + cohort suspended after first step for lack of efficacy of cetuximab.

Results Point of Contact

• Title: Dr. Rashmi Chugh
• Organization: University of Michigan Comprehensive Cancer Center

rashmim@umich.edu

(734) 936-5710

Study Officials

• Rashmi Chugh, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: June 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2009
• Last Updated: January 24, 2013
• Results First Posted: September 12, 2011

Record last verified: 2013-01

Locations

US (1)