Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: cetuximab; cisplatin
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  GOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No significant history of cardiac disease within the past 6 months, including the
             following:

               -  Unstable angina

               -  Uncontrolled hypertension

               -  Uncontrolled congestive heart failure

               -  Uncontrolled arrhythmia

        Neurologic

          -  No uncontrolled seizure disorder

          -  No active neurological disease

          -  No neuropathy (sensory and motor) > grade 1

        Other

          -  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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior anti-epidermal growth factor receptor (EGFR) antibody therapy

          -  No prior chimerized or murine monoclonal antibody therapy

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  At least 1 week since prior anticancer hormonal therapy

          -  Concurrent hormone replacement therapy allowed

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

        Surgery

          -  More than 30 days since prior major surgery, except diagnostic biopsy

        Other

          -  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