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Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292955
Recruitment Status : Unknown
Verified May 2011 by University of Virginia.
Recruitment status was:  Recruiting
First Posted : February 16, 2006
Last Update Posted : May 30, 2011
Bristol-Myers Squibb
Eli Lilly and Company
Washington University School of Medicine
Information provided by:
University of Virginia

Brief Summary:
The anti-tumor activity of cetuximab prior to chemoradiotherapy and the safety and tolerability of cetuximab with concurrent chemoradiation will be determined in women with locally advanced or metastatic cervical carcinoma.

Condition or disease Intervention/treatment Phase
Cancer of the Cervix Drug: Cetuximab Phase 2

Detailed Description:
  • 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 therapy
  • Follow for tumor recurrence and survival

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Pharmacogenomic Study of Neoadjuvant Cetuximab Followed by Cisplatin, Radiotherapy, and Cetuximab in Women With Newly Diagnosed Locally Advanced or Metastatic Cervical Carcinoma
Study Start Date : February 2006
Estimated Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Intervention Details:
  • Drug: Cetuximab
    monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.

Primary Outcome Measures :
  1. To identify genes that may be identified as predictive of response to cetuximab [ Time Frame: completion ]
  2. To sequence the epidermal growth factor receptor (EGFR) to describe mutations in the receptor that may predict tumor response to cetuximab [ Time Frame: completion ]
  3. To evaluate the validity of fluorodeoxyglucose (FDG) uptake, as determined by positron emission tomography (PET) imaging, as a surrogate marker for response to cetuximab [ Time Frame: completion ]

Secondary Outcome Measures :
  1. To determine the safety and tolerability of cetuximab with concurrent chemoradiation in women with locally advanced cervical carcinoma [ Time Frame: weekly ]
  2. To determine the progression-free and overall survival in women with locally advanced or metastatic cervical carcinoma treated with concurrent chemoradiation and cetuximab [ Time Frame: every three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 cervix.
  7. Patients must be newly diagnosed with locally advanced or metastatic cervical carcinoma.
  8. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mcl; platelets > 100,000/mcl.
  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 placement.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292955

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Contact: Meredith Gross, M.S. 434-924-0436

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United States, Missouri
Washinton University School of Medicine Suspended
St. Louis, Missouri, United States, 63110
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Bristol-Myers Squibb
Eli Lilly and Company
Washington University School of Medicine
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Principal Investigator: Linda R. Duska, M.D. University of Virginia
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Responsible Party: Linda R. Duska, M.D, University of Virginia Identifier: NCT00292955    
Other Study ID Numbers: IRB-HSR#13748
HRPO #05-0702
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011
Keywords provided by University of Virginia:
Cervical Cancer, Cetuximab, Phase II Clinical Trials
Stage IB2-IVB Carcinoma of the Cervix
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents