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An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma

Phase 2
18 Years
Open (Enrolling)
Cancer of the Cervix

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Trial Information

An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma

- Women with Federation of Gynecology and Obstetrics (FIGO) Clinical Stage IB2-IVB
carcinoma of the cervix

- Baseline cervical biopsy, blood samples, and FDG-PET/computed tomography (CT) scan

- Cetuximab 400 mg/m2 on day 1 followed by cetuximab 250 mg/m2 on days 8 and 15

- Repeat cervical biopsy and FDG-PET/CT scan following cetuximab monotherapy

- Radiation and weekly cisplatin 40 mg/m2 and cetuximab 250 mg/2 for 6 weeks

- Cetuximab 250 mg/m2 weekly for 12 weeks

- Repeat cervical biopsy (if tumor present) and FDG-PET/CT scan after completion of

- Follow for tumor recurrence and survival

Inclusion Criteria:

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
repeated biopsy.

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).

Exclusion Criteria:

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. 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

13. Incarceration

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To identify genes that may be identified as predictive of response to cetuximab

Outcome Time Frame:


Safety Issue:


Principal Investigator

Linda R. Duska, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Cancer of the Cervix
  • Cervical Cancer, Cetuximab, Phase II Clinical Trials
  • Stage IB2-IVB Carcinoma of the Cervix
  • Carcinoma
  • Uterine Cervical Neoplasms



University of Virginia Cancer Center Charlottesville, Virginia  22908
Washinton University School of Medicine St. Louis, Missouri  63110