Gefitinib in Treating Patients With Cervical Cancer

NCT00049556 | Completed Phase 2

• 3 other identifiers: CDR0000258117NCI-02-C-0303NCI-5561
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cervical Cancer; Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

fallopian tube cancer; borderline ovarian surface epithelial-stromal tumor; primary peritoneal cavity cancer; recurrent cervical cancer; recurrent ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• 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)

• 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

• Clinical activity of gefitinib as measured by CT scan of chest/abdomen/pelvis every 8 weeks

• Toxicity as measured by laboratory testing, history, physical exam, and patient diary every 4 weeks

• 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

• 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

Interventions

gefitinib DRUG

immunohistochemistry staining method OTHER

surface-enhanced laser desorption/ionization-time of flight mass spectrometry OTHER

biopsy PROCEDURE

sentinel lymph node biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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):1323-30. doi: 10.1002/cncr.22545.

  PMID: 17330838 RESULT

• 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 County, CA. A-5745, 2005. .

  RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Gefitinib; Immunohistochemistry; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; Biopsy; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Mass Spectrometry; Chemistry Techniques, Analytical; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision

Study Officials

• Virginia Kwitkowski, MS, RN, CS, CRNP

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2002
• Study Completion: August 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2006-01

Locations

US (2)