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Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma
This study is currently recruiting participants.
Verified by Washington University School of Medicine, May 2008
Sponsors and Collaborators: Washington University School of Medicine
Bristol-Myers Squibb
ImClone Systems
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00292955
  Purpose

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 Intervention Phase
Cancer of the Cervix
Drug: Cetuximab
Phase II

MedlinePlus related topics: Cancer Cervical Cancer
Drug Information available for: Cisplatin Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To identify genes that may be identified as predictive of response to cetuximab [ Time Frame: completion ] [ Designated as safety issue: No ]
  • To sequence the epidermal growth factor receptor (EGFR) to describe mutations in the receptor that may predict tumor response to cetuximab [ Time Frame: completion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and tolerability of cetuximab with concurrent chemoradiation in women with locally advanced cervical carcinoma [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2006
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    monotherapy (day 1), then weekly thereafter along with radiation. dose is at 200mg/m2.
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292955

Contacts
Contact: Kathryn Britton 314-747-4126 brittonk@ccadmin.wustl.edu
Contact: Stephanie Myles 314-747-4223 myless@ccadmin.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Bristol-Myers Squibb
ImClone Systems
Investigators
Principal Investigator: Paula M Fracasso, M.D., Ph.D. Washington University School of Medicine
  More Information

Responsible Party: University of Virginia ( Paula M. Fracasso, M.D., Ph.D. )
Study ID Numbers: 05-0702, CA225243
Study First Received: February 14, 2006
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00292955  
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Cervical Cancer, Cetuximab, Phase II Clinical Trials
Stage IB2-IVB Carcinoma of the Cervix

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Cisplatin
Cetuximab
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009