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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278343 |
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cediranib maleate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer |
Estimated Enrollment: | 64 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to reaction to prior platinum-based regimen (sensitive vs insensitive).
Patients receive oral AZD2171 once daily for 4 weeks. Courses repeat every 4 weeks for up to 8 months in the absence of disease progression or toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 64 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:
Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
Measurable or evaluable disease, as defined by 1 of the following:
Patients must have received platinum-based chemotherapy prior to study entry
PATIENT CHARACTERISTICS:
No New York Heart Associated class III or IV disease
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
Canada, Ontario | |
Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 5P9 | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Ottawa Hospital Regional Cancer Centre - General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Hopital Notre-Dame du CHUM | |
Montreal, Quebec, Canada, H2L 4M1 |
Study Chair: | Hal W. Hirte, MD, FRCP(C) | Margaret and Charles Juravinski Cancer Centre |
Study ID Numbers: | CDR0000456204, PMH-PHL-037, NCI-7129 |
Study First Received: | January 16, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00278343 |
Health Authority: | United States: Food and Drug Administration |
recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Ovarian 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 Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |