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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00445549 |
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well vandetanib works in treating patients with refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: vandetanib Genetic: protein expression analysis Genetic: proteomic profiling Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy Procedure: dynamic contrast-enhanced magnetic resonance imaging |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | Phase II Study of Clinical Activity and Proteomic Pathway Profiling of the VEGFR2 Inhibitor, ZD6474 (Vandetanib) in Women With Relapsed or Refractory Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Estimated Enrollment: | 38 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized study.
Patients receive oral vandetanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo core biopsies of a sentinel lesion at baseline and at 6 weeks after beginning study therapy. Tumor tissue lysates are arrayed and analyzed by protein proteomics for phosphorylated (p)-vascular endothelial growth factor receptor (VEGFR) 2, p-epidermal growth factor receptor (EGFR), p-ERK, and P-AKT. VEGFR2, p-VEGFR2, EGFR, and p-EGFR expression are analyzed by immunohistochemistry. VEGF, interleukin (IL)-6, and IL-8 are measured by enzyme-linked immunosorbent assay. Patients undergo dynamic contrast-enhanced MRI at baseline, on day 3 of course 1, and at 6 weeks after beginning study therapy.
Patients complete a quality of life questionnaire at baseline and after 4 weeks, 8 weeks, and 16 weeks of treatment.
After completion of study treatment, patients are followed monthly.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Relapsed disease OR disease refractory to prior standard platinum- and taxane-based therapy
PATIENT CHARACTERISTICS:
No history of clinically significant cardiac disorders, including any of the following:
Uncontrolled symptomatic arrhythmia, including any of the following:
No active infection
No prior or concurrent malignancies within the past 5 years except for the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Elise C. Kohn, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000532810, NCI-07-C-0061, NCI-P7041 |
Study First Received: | March 7, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00445549 History of Changes |
Health Authority: | United States: Food and Drug Administration |
peritoneal cavity cancer fallopian tube cancer recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer |
Fallopian Tube Cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Fallopian Tube Neoplasms |
Recurrence Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Fallopian Tube Neoplasms |
Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |