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Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

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: NCT00101192
Recruitment Status : Completed
First Posted : January 10, 2005
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
National Cancer Institute (NCI)
Bristol-Myers Squibb
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin may be a better way to block tumor growth.

PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Biological: cetuximab Drug: cisplatin Phase 2

Detailed Description:



  • Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent carcinoma of the cervix.
  • Determine the nature and degree of toxicity of this regimen in these patients.


  • Determine the progression-free survival and overall survival of patients treated with this regimen.
  • Correlate epidermal growth factor receptor expression with progression-free survival, overall survival, and response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and cisplatin IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
Study Start Date : September 2004
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Primary Outcome Measures :
  1. Tumor Response [ Time Frame: up to 6 months from study entry ]

    Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria:

    Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

    Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions.

    Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Stable Disease: any condition not meeting the above criteria.

    Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Secondary Outcome Measures :
  1. Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment [ Time Frame: up to 5 years from study entry ]

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


  • Histologically confirmed squamous or non-squamous cell carcinoma of the cervix

    • Advanced, persistent, or recurrent disease
    • Documented disease progression
  • Not amenable to curative therapy
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • At least 1 target lesion

    • Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence



  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified


  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN


  • Creatinine ≤ 1.5 times ULN


  • No significant history of cardiac disease within the past 6 months, including the following:

    • Unstable angina
    • Uncontrolled hypertension
    • Uncontrolled congestive heart failure
    • Uncontrolled arrhythmia


  • No uncontrolled seizure disorder
  • No active neurological disease
  • No neuropathy (sensory and motor) > grade 1


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer


Biologic therapy

  • No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
  • No prior chimerized or murine monoclonal antibody therapy


  • Not specified

Endocrine therapy

  • At least 1 week since prior anticancer hormonal therapy
  • Concurrent hormone replacement therapy allowed


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy


  • More than 30 days since prior major surgery, except diagnostic biopsy


  • Recovered from all prior therapy
  • No prior cytotoxic therapy for cervical cancer
  • No prior tyrosine kinase inhibitor therapy that targets the EGFR pathway
  • No prior cancer treatment that would contraindicate study therapy
  • No other concurrent investigational agents

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): NCT00101192

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United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Christus Schumpert Cancer Treatment Center
Shreveport, Louisiana, United States, 71101
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Bristol-Myers Squibb
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Study Chair: John H. Farley, MD Uniformed Services University of the Health Sciences

Publications of Results:
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Responsible Party: Gynecologic Oncology Group Identifier: NCT00101192     History of Changes
Other Study ID Numbers: GOG-0076DD
First Posted: January 10, 2005    Key Record Dates
Results First Posted: March 17, 2014
Last Update Posted: March 17, 2014
Last Verified: February 2014

Keywords provided by Gynecologic Oncology Group:
recurrent cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma
cervical squamous cell carcinoma
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Antineoplastic Agents, Immunological