An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma
1. Patients must have signed a Washington University, Human Studies Committee (HSC)
approved, informed consent.
2. Patients must have primary, histologically documented FIGO Clinical Stage IB2-IVB
invasive carcinoma of the uterine cervix with measurable disease amendable to
3. Patients must have an ECOG performance status of 0, 1, or 2 at study entry.
4. Patients, 18 years and 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. Women should not breast feed while on this study.
5. Women must have a primary diagnosis of invasive carcinoma of the uterine cervix. Men
are excluded from this study as a consequence of the diagnosis being investigated.
6. Patients must have had no previous treatment for invasive carcinoma of the uterine
7. Patients must be newly diagnosed with locally advanced or metastatic cervical
8. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mcl; platelets >
9. Renal function: creatinine ≤ 2.0 mg/dl.
10. Hepatic function: bilirubin ≤ 1.5 times upper limit normal (ULN); SGOT ≤ 2.5 times
upper limit normal (ULN).
11. Patients with ureteral obstruction must be treated with stent or nephrostomy tube
12. Patients with neuropathy (sensory and motor) must be ≤ grade 1 defined by National
Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version
3.0 (June 10, 2003).
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
7. A serious uncontrolled medical disorder that in the opinion of the Investigator would
impair the ability of the subject to receive protocol therapy.
8. Unresolved ureteral obstruction.
9. Renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplant,
that would require modification of radiation fields.
10. Known or documented brain metastases.
11. Any concurrent malignancy other than non-melanoma skin cancer. (Patients with a
previous malignancy but without evidence of disease for ≥ 5 years will be allowed to
enter the trial).
12. Prior radiation therapy to the abdomen and/or pelvis