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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bristol-Myers Squibb
ImClone LLC
Washington University School of Medicine
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00292955
First received: February 14, 2006
Last updated: May 26, 2011
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

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 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Meredith Gross, M.S. 434-924-0436 mpg8b@virginia.edu

Locations
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
ImClone LLC
Washington University School of Medicine
Investigators
Principal Investigator: Linda R. Duska, M.D. University of Virginia
  More Information

No publications provided

Responsible Party: Linda R. Duska, M.D, University of Virginia
ClinicalTrials.gov Identifier: NCT00292955     History of Changes
Other Study ID Numbers: IRB-HSR#13748, CA225243, HRPO #05-0702
Study First Received: February 14, 2006
Last Updated: May 26, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014