Clinical trial · Interventional
Gefitinib in Treating Patients With Cervical Cancer
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
NCT00049556CI-TRIAL-00010869completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| gefitinib | Drug | Gefitinib | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
| surface-enhanced laser desorption/ionization-time of flight mass spectrometry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
Secondary outcomes (7)
- measure
- 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
- measure
- Clinical activity of gefitinib as measured by CT scan of chest/abdomen/pelvis every 8 weeks
- measure
- Toxicity as measured by laboratory testing, history, physical exam, and patient diary every 4 weeks
- measure
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (2)
- RESULTPosadas 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):1323-30. doi: 10.1002/cncr.22545. PMID 17330838
- RESULTLiel 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 County, CA. A-5745, 2005. .