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| Tracking Information | |||||
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| First Received Date ICMJE | July 5, 2000 | ||||
| Last Updated Date | February 26, 2009 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006014 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | SU5416 in Treating Patients With Malignant Mesothelioma | ||||
| Official Title ICMJE | A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma | ||||
| Brief Summary | RATIONALE: SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant mesothelioma. |
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| Detailed Description | OBJECTIVES: I. Determine the objective response rate, median and overall survival, and time to progression in patients with unresectable malignant mesothelioma treated with SU5416. II. Determine the effect of SU5416 on surrogate biologic endpoints, including microvessel density, tissue proliferative index, apoptosis, vascular endothelial growth factor levels, and tumor perfusion measured by MRI in these patients. III. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 21-45 patients will be accrued for this study within 18-24 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Malignant Mesothelioma | ||||
| Intervention ICMJE | Drug: semaxanib | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically or cytologically proven malignant mesothelioma (epithelial, sarcomatoid, or mixed subtype) that is not amenable to surgery or radiotherapy Measurable disease At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan Pleural effusions and ascites are not considered measurable lesions Only site of measurable disease must not be located within prior radiotherapy port Lesion must be accessible for biopsy History of previously treated CNS metastasis allowed if: Neurologically stable No requirement for IV or oral steroids or IV anticonvulsants No active or residual disease by brain CT or MRI scan Patients with neurologic signs or symptoms suggestive of CNS metastasis must have a negative brain CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination No history of myocardial infarction or severe/unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep vein or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: No significant uncontrolled underlying medical or psychiatric illness No serious active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix Patients are not considered to have active malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior systemic chemotherapy regimen At least 4 weeks since prior systemic chemotherapy and recovered Prior intrapleural cytotoxic agents (including bleomycin) allowed No concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drug and recovered No concurrent investigational drug |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006014 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068023, UCCRC-10409, UCCRC-NCI-44, NCI-44 | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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