Phase II Pilot Study of Clinical Activity and Proteomic Pathway Profiling of the EGFR Inhibitor, ZD1839 (Iressa; Gefitinib), in Patients With Epithelial Ovarian Cancer or Cervical Cancer
Trial ID: NCT00049556
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: PHASE2
Start date: 2002-10
Completion date: 2006-08
Sponsor: National Cancer Institute (NCI)
Conditions: Cervical Cancer; Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
Interventions: gefitinib; immunohistochemistry staining method; surface-enhanced laser desorption/ionization-time of flight mass spectrometry; biopsy; sentinel lymph node biopsy
Locations: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; NCI - Center for Cancer Research
Countries: United States; United States
Age range: 18 Years - None
Sex: FEMALE

Summary:
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.

Eligibility criteria:
DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

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

Hepatic

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

Renal

* Creatinine less than 1.5 mg/dL

Cardiovascular

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

Other

* 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior cetuximab or monoclonal antibody ABX-EGF

Chemotherapy

* 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

Radiotherapy

* At least 4 weeks since prior radiotherapy and recovered

Surgery

* Recovered from prior oncologic or other major surgery

Other

* 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)

Outcomes:
Biochem. modulation of EGFR signal transduction pathways in tumor by tissue lysate array reduction in phosphorylation of EGFR , AKT, and ERK in tumor biopsies at baseline and at 4 weeks during therapy