Gefitinib in Treating Patients With Cervical Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentCompleted18 and overNCICDR0000258117
NCI-02-C-0303, NCI-5561, 5561, NCT00049556

Trial Description


RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of cervical cancer. Comparing results of diagnostic procedures performed before, during, and after treatment with gefitinib may help doctors predict a patient's response to treatment and help plan the most effective treatment.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with cervical cancer.

Further Study Information


  • Determine the reduction in phosphorylation of epidermal growth factor receptor (EGFR), AKT, and ERK by proteomics in tumor and normal skin of patients with ovarian epithelial cancer or cervical cancer receiving gefitinib. (Open to accrual for cervical cancer patients only as of 4/5/2005)
  • Determine the clinical activity of this drug in these patients.
  • Determine the toxicity of this drug in these patients.
  • Correlate the biologic modulation of EGFR, ERK, and AKT by this drug with outcome and toxic effects in these patients.
  • Correlate EGFR modulation in skin with outcome and toxic effects in patients treated with this drug.
  • Correlate expression of EGFR and phosphorylated-EGFR in tissue biopsies from these patients with biochemical modulation and outcome.
  • Determine the application of surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) and artificial intelligence bioinformatics to serially obtained serum samples for predicting response and toxic effects in these patients.

OUTLINE: Patients are stratified according to disease (cervical cancer vs ovarian epithelial, fallopian tube, and primary peritoneal cancer). (Open to accrual for cervical cancer patients only as of 4/5/2005)

Patients receive oral gefitinib daily. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Biopsies of a sentinel lesion (with CT guidance or laparoscopy) are obtained at baseline and at 4 weeks. Skin biopsies of unaffected areas are also obtained at these time points. Tissue is examined using immunohistochemical methods. Proteomic profiling using surface-enhanced laser desorption/ionization with time-of-flight (SELDI-TOF) mass spectrometry is conducted on serum at baseline and then every 4 weeks.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 30-40 patients (15-20 per stratum) will be accrued for this study within 10-12 months. (Open to accrual for cervical cancer patients only as of 4/5/2005)

Eligibility Criteria


  • Histologically confirmed ovarian epithelial cancer or cervical cancer (open to accrual for cervical cancer patients only as of 4/5/2005)
  • Relapsed or refractory
  • The following are also eligible: (open to accrual for cervical cancer patients only as of 4/5/2005)
  • Cancer of the fallopian tube
  • Primary peritoneal cancer
  • Cancer with low malignant potential and an invasive recurrence
  • Block or recuts of primary tumor or recent resection specimen of a metastatic site required
  • Measurable disease with a sentinel lesion adequate for core biopsy by percutaneous biopsy or laparoscopy
  • No CNS involvement



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin less than 1.5 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal


  • Creatinine less than 1.5 mg/dL


  • No myocardial infarction within the past 6 months
  • No unstable dysrhythmia within the past 6 months


  • No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer
  • No active ocular inflammation or infection
  • No active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study


Biologic therapy

  • No prior cetuximab or monoclonal antibody ABX-EGF


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • At least 4 weeks since prior hormonal therapy and recovered
  • No concurrent tamoxifen


  • At least 4 weeks since prior radiotherapy and recovered


  • Recovered from prior oncologic or other major surgery


  • No prior epidermal growth factor receptor inhibitory agents (e.g., OSI-774)
  • No concurrent antiretroviral therapy
  • No concurrent itraconozole, ketoconazole, erythromycin, verapamil, chlorpromazine, amiodarone, or chloroquine
  • No concurrent drugs known to induce CYP3A4 enzymes (e.g., phenytoin, carbamazepine, rifampicin, barbiturates, oxacarbazepine, rifapentine, or Hypericum perforatum)

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Virginia Kwitkowski, Study Chair

    Link to the current record.
    NLM Identifier NCT00049556 processed this data on April 09, 2015

    Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to