Cetuximab in Patients With Progressive or Recurrent Endometrial Cancer

NCT00392769 | Completed Phase 2 Results

• 1 other identifier: 2006-0211
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical research study is to learn if cetuximab can help to control the disease in patients who have recurrent endometrial cancer. Primary Objective: 1\. To determine the overall disease control rate of cetuximab in patients with progressive or recurrent endometrial cancer. Secondary Objectives:

1. 1.To determine the duration of disease control, time to disease progression, and survival of this cohort of patients.
2. 2.To determine the nature and degree of toxicity of cetuximab in this cohort of patients.
3. 3.To correlate biologic markers with response to therapy if tissue is available.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Progressive or Recurrent Endometrial Cancer; Cetuximab; C225; Erbitux™; IMC-C225; Epidermal growth factor receptor; EGFR; Endometrioid Tumor; Serous Tumor; Clear cell Tumor; Mixed malignant Mullerian Tumors

Outcome Measures

Primary Outcomes (1)

• Overall Disease Control Rate

  Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.

  Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.

Study Arms (1)

Cetuximab

EXPERIMENTAL

400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.

Drug: Cetuximab

Interventions

Cetuximab DRUG

Initial Dose = 400 mg/m\^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m\^2 IV Over 60 Minutes.

Also known as: C225, Erbitux™, IMC-C225

Cetuximab

Eligibility Criteria

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

You may qualify if:

• Patients must have signed an approved informed consent.
• Histologically confirmed progressive or recurrent endometrial cancer (endometrioid, serous, clear cell, mixed malignant Mullerian tumors, or mixed histology; any grade).
• Patients must have failed at least one prior chemotherapeutic regimen for recurrent disease (does not include chemosensitizing radiation).
• All patients must have measurable disease. Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be \> 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \> 10 mm when measured by spiral CT. Ascites and pleural effusions are not considered measurable disease. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
• Patients must have a Zubrod performance status of 0, 1, or 2.
• Patients 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 for greater than 12 months.
• Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of \>1,000/Fl, a hemoglobin level of \>/= 9.0 gm/dL and a platelet count of \>75,000/Fl.
• Patients must have an adequate renal function as documented by serum creatinine \</= 2.0 mg/dL.
• Patients must have adequate hepatic function as documented by a serum bilirubin \</= 2.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor.
• Aspartate transaminase (SGOT) must be \</= 3x institutional upper limit of normal unless the liver is involved with tumor, in that case, the aspartate transaminase must be \</=5 x institutional upper limit of normal.
• Prior to beginning therapy, at least 4 weeks must have elapsed since prior chemotherapy, surgery, radiation therapy or investigational therapy. Patients receiving palliative radiation therapy are exempt from the 4 week waiting period.

You may not qualify if:

• Patients who have uterine sarcomas.
• Patients who have isolated recurrences (vaginal, pelvic, or paraaortic) that are amenable to potentially curative treatment with radiation therapy or surgery.
• Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
• Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
• Patients with active or uncontrolled systemic infection.
• Patients with 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 an ejection fraction under 40%.
• Patients who received prior therapy that specifically and directly targets the EGFR pathway.
• Patients who experienced prior severe infusion reaction to a monoclonal antibody.
• Patients who are pregnant or breast feeding.
• Presence of clinically apparent untreated central nervous system metastases.
• Patients with carcinomatous meningitis.
• Patients with deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry. Patients may be on maintenance anticoagulation therapy.
• Patients with previously documented human immunodeficiency virus (HIV) infection.
• Patients currently receiving chemotherapy or radiation therapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (2)

New York Presbyterian Hospital-Cornell Medical Center

New York, New York, 10021, United States

Location

UT MD . Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Judith Wolff, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Judith Wolf, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 6, 2012
• Results First Posted: September 6, 2012

Record last verified: 2012-08

Locations

US (2)