Ovarian Cancer Clinical Trial
Official title:
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
Verified date | January 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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) |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NCI - Center for Cancer Research | Bethesda | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Liel MS, Espina V, Pazzagli C, et al.: Phase II study of gefitinib in epithelial ovarian cancer: Proteomic pathway profiling in tumor biopsies. [Abstract] American Association for Cancer Research: 96th Annual Meeting, April 16-20, 2005, Anaheim/Orange Cou
Posadas EM, Liel MS, Kwitkowski V, Minasian L, Godwin AK, Hussain MM, Espina V, Wood BJ, Steinberg SM, Kohn EC. A phase II and pharmacodynamic study of gefitinib in patients with refractory or recurrent epithelial ovarian cancer. Cancer. 2007 Apr 1;109(7) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | ||
Secondary | Biochem. modulation of EGFR signal transduction pathways in skin biopsy tissue by tissue lysate array reduction in phosphorylation of EGFR , AKT, and ERK in skin biopsies at baseline and at 4 weeks during therapy | No | ||
Secondary | Clinical activity of gefitinib as measured by CT scan of chest/abdomen/pelvis every 8 weeks | No | ||
Secondary | Toxicity as measured by laboratory testing, history, physical exam, and patient diary every 4 weeks | Yes | ||
Secondary | Skin as a surrogate site for study of EGFR modulation and correlation with outcome and toxicity as measured by tissue lysate arrays at baseline and 4 weeks after the start of study therapy | Yes | ||
Secondary | Potential collateral activation of other signal pathways in tumor and skin as measured by tissue lysate arrays at baseline and 4 weeks after the start of study therapy | No | ||
Secondary | Expression of EGFR and phosphorylated-EGFR (pY-EGFR) as measured by tissue lysate arrays at baseline and 4 weeks after the start of study therapy | No | ||
Secondary | Prediction of response and/or toxicity by serially obtained serum samples using surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) and artificial intelligence bioinformatics at baseline and then monthly | Yes |
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