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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often receive the most effective healthcare possible for their 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 condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Fallopian Tube Cancer,Ovarian Cancer
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: The purpose of this study is to determine whether the investigational drug, 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Disease Characteristics: - Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer - Recurrent 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) Prior/Concurrent Therapy: - Surgery: No major surgery within 4 weeks of CA-125 assessment. No major medical interference with the peritoneum or pleura within 4 weeks of CA-125 assessment - Chemotherapy: At least 4 weeks since prior first-line platinum-based regimen only with or without maintenance paclitaxel IV therapy - Hormonal-based therapy: At least 4 weeks since prior hormonal therapy for ovarian cancer - Investigational therapy: At least 4 weeks since Investigational therapy - Resolution to Common Toxicity Criteria (CTC) Grade <= 2 or baseline of any toxic side effects related to prior chemotherapy or hormonal therapy, excluding alopecia - Other: a) No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide b) No prior consolidation therapy with cytotoxic agents for ovarian cancer c) Continuation of hormone replacement therapy is permitted d) No requirement for concomitant anticoagulant therapy. Administration of low dose anticoagulants for maintenance of central venous access is permitted e)No chronic oral or intravenous steroid use Patient Characteristics: - Age >= 26 years. Subjects between ages 18 and 26 will be eligible provided closure of the epiphyses has been documented by an appropriate radiographic scan - Subjects must be asymptomatic - Performance status: ECOG 0-1 and life expectancy >6 months - Biochemical and hematologic parameters must be obtained within 3 weeks of study entry as follows: a) Hematologic: absolute neutrophil count (ANC) >= 1500/mm3; platelet count >= 100,000/mm3) b) Renal: serum creatinine <= 1.5 x ULN or estimated creatinine clearance of >= 60 ml/min c) Hepatic: total bilirubin <= 1.5 x institutional ULN; alkaline phosphatase <= 2.5 x ULN; alanine transaminase (ALT) and/or aspartate transaminase (AST) <= 2.5 x ULN d) Other: PT, PTT and INR <= 1.5 x ULN - No other cancers during the last 3 years except treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in site of the cervix - No clinically significant gastrointestinal abnormalities including:a)inability to take oral medication b)requirement for intravenous alimentation c)malabsorption syndromes d)treatment of active ulcer disease within the past 3 months e)prior gastric resection f)active gastrointestinal bleeding, unrelated to cancer, as evidenced by either hematemesis, hematochezia or melena within the past 3 months - Cardiovascular: a) No evidence of preexisting uncontrolled hypertension b) No history of CTC Grade >= 2 hemorrhage or thrombotic cerebrovascular event (including TIA) within the past 12 months c) No clinically significant cardiac disease as defined below: 1)unstable angina 2) decompensated congestive heart failure or myocardial infarction within the last 6 months 3)serious cardiac arrhythmias or conduction abnormalities including any history of recurrent ventricular arrhythmia within the past 6 months 4)diagnosis of cardiomyopathy 5)Requirement for antiarrhythmics (beta blockers or calcium channel blockers used for other indications are allowed) 6)QTc>460 msec on Prestudy ECG 7)history of syncope (associated with arrhythmia) - No serious, uncontrolled medical disorder including any bleeding disorders, uncontrolled diabetes or active infection, which would impair the ability to receive study drug - Dementia, altered mental status, or uncontrolled psychiatric illness that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol - Subjects who are pregnant or breast-feeding - If subjects are of childbearing potential, they must use an adequate method of contraception or have a male partner that is sterile . Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy - Voluntary and written informed consent must be given
Total Enrollment: 29
Location and Contact Information:
Pfizer Investigational Site *Recruiting*
New York City, New York, 10016
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting
Pfizer Investigational Site *Recruiting*
New York City, New York, 10016
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting
Pfizer Investigational Site *Not yet recruiting*
Santa Monica, California, 90404
United States
Not yet recruiting
Pfizer Investigational Site *Not yet recruiting*
Los Angeles, California, 90095
United States
Not yet recruiting
Pfizer Investigational Site *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting
Pfizer Investigational Site *Recruiting*
New York City, New York, 10016
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting
Pfizer Investigational Site *Not yet recruiting*
Baltimore, Maryland, 21237
United States
Not yet recruiting
Additional Information:
Study ID Numbers: A3521003;
Study Start Date: November 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074867
Other Fallopian Tube Cancer Studies:
1. Acupuncture to Improve Quality of Life in Patients With Advanced Cancer
2. Clinical Trial for Ovarian Cancer (OvaRex®)
3. Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
4. A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833
5. Phase 2 study of ET-743 in subjects with advanced ovarian cancer
Related Studies:
Other Fallopian Tube Cancer Clinical Trials
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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
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