- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00074867
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer
November 6, 2006 updated by: Pfizer
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1R 2J6
- Pfizer Investigational Site
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Pfizer Investigational Site
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California
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Los Angeles, California, United States, 90095
- Pfizer Investigational Site
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Santa Monica, California, United States, 90404
- Pfizer Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21237
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Pfizer Investigational Site
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Boston, Massachusetts, United States, 02115
- Pfizer Investigational Site
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Boston, Massachusetts, United States, 02215
- Pfizer Investigational Site
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New York
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New York, New York, United States, 10016
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancerRecurrent or persistent elevated CA-125.
- For the purpose of this study, elevated CA-125 is defined as a value of ≥40 U/ml on two separate consecutive determinations made ≥1 week apart.
- CA-125 values obtained within 4 weeks of abdominal surgery should not be taken into account.
- No definitive disease or clinical and findings of small volume disease (£1cm by spiral CT or £2cm by conventional CT or clinical exam).
Exclusion Criteria:
- No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide.
- No prior consolidation therapy with cytotoxic agents for ovarian cancer.
- Continuation of hormone replacement therapy is permitted.
- No requirement for concomitant anticoagulant therapy.
- Administration of low dose anticoagulants for maintenance of central venous access is permitted.No chronic oral or intravenous steroid use.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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At the completion of Stage 1 of the study, it did not meet the objective response criteria to proceed to Stage 2 of the trial.
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Secondary Outcome Measures
Outcome Measure |
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Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Study Completion
September 1, 2004
Study Registration Dates
First Submitted
December 22, 2003
First Submitted That Met QC Criteria
December 23, 2003
First Posted (Estimate)
December 24, 2003
Study Record Updates
Last Update Posted (Estimate)
November 7, 2006
Last Update Submitted That Met QC Criteria
November 6, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
Other Study ID Numbers
- A3521003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Neoplasms
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Ovarian Neoplasm | Ovarian Clear Cell Tumor | Adnexal Mass | Ovarian Endometrioid Tumor | Ovarian Serous Tumor | Borderline Ovarian Epithelial TumorUnited States
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Maastricht University Medical CenterVieCuri Medical Centre; Orbis Medical Centre; St.Jans Gasthuis Weert; Laurentius...TerminatedOvarian Cancer | Ovarian Carcinoma | Ovarian Cyst | Ovarian MassNetherlands
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Medical University of LublinCompletedOvarian Cancer | Unexplained Infertility | Borderline Ovarian Tumors | Benign Ovarian TumorPoland
Clinical Trials on CP-547,632
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited States
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PfizerCompletedLung NeoplasmsUnited States
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Brigham and Women's HospitalRecruiting
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PfizerTerminatedObesityUnited States, Australia, Canada, Brazil, Slovakia, Czech Republic, Argentina, Germany, Mexico, United Kingdom, Sweden
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Janssen Pharmaceutical K.K.Completed
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Siemens Molecular ImagingTerminatedBreast CancerUnited States
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PfizerTerminatedObesityAustralia, United States, Korea, Republic of, Spain, France, United Kingdom, Germany, Sweden, Argentina, Chile, Mexico
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PfizerTerminatedObesityUnited States, Canada
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University of California, San FranciscoCalifornia Breast Cancer Research ProgramCompleted
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Institute for Clinical and Experimental MedicineRecruitingMyocardial Infarction | Shock, Cardiogenic | Remodeling, VentricularCzechia