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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


OBJECTIVES:

- 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)

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Virginia Kwitkowski, MS, RN, CS, CRNP

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000258117

NCT ID:

NCT00049556

Start Date:

October 2002

Completion Date:

August 2006

Related Keywords:

  • Cervical Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • fallopian tube cancer
  • borderline ovarian surface epithelial-stromal tumor
  • primary peritoneal cavity cancer
  • recurrent cervical cancer
  • recurrent ovarian epithelial cancer
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
NCI - Center for Cancer ResearchBethesda, Maryland  20892