Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
1998-07-31
2003-12-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating patients who have advanced malignant solid tumors.
Detailed Description
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OUTLINE: This is an open label, dose escalation, multicenter study. Patients receive IV combretastatin A4 phosphate over 10 minutes once a week for 3 weeks. Patients not experiencing unacceptable toxic effects begin individual dose escalation, receiving a maximum of 3 dose levels with 2 weeks of rest between each dose level. Dose escalation stops when 2 patients have experienced dose limiting toxicity (DLT) at a particular dose level. Once DLT is established, at least 6 patients are treated at a lower dose to determine the maximum tolerated dose. Patients may receive up to 6 courses of 3 infusions each. Patients are followed for 4 weeks.
PROJECTED ACCRUAL: Approximately 30-35 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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fosbretabulin disodium
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 4 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.17 mg/dL ALT or AST less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN (unless due to liver or bone metastases) Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No ischemic heart disease Other: Not pregnant or nursing Fertile patients must use effective contraception at least 4 weeks before, during, and for 4 weeks after the study No other serious medical condition or serious infection within past 28 days No other active concurrent malignancies, except: Carcinoma in situ of the cervix Adequately treated basal or squamous cell carcinoma of the skin No autoimmune disorders No inflammatory bowel disease No diabetes
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior nitrosoureas or mitomycin and recovered Endocrine therapy: Concurrent steroid use allowed Radiotherapy: At least 6 weeks since prior radiotherapy (except radiotherapy to small isolated fields not including significant areas of bone marrow) and recovered No prior radiotherapy to tumor site(s) that will be imaged by MRI/PET scanning or used to assess tumor response Surgery: No concurrent open surgery Other: At least 4 weeks since all other prior anticancer therapies and recovered No concurrent heparin or warfarin Concurrent NSAIDs allowed
18 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
Principal Investigators
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Gordon J.S. Rustin, MD
Role: STUDY_CHAIR
Mount Vernon Cancer Centre at Mount Vernon Hospital
Locations
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Mount Vernon Hospital
Northwood, England, United Kingdom
Countries
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References
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Galbraith SM, Taylor NJ, Maxwell RJ, et al.: Combretastatin A4 phosphate (CA4P) targets vasculature in animal and human tumors. [Abstract] Br J Cancer 83 (suppl 1): A-1.7, 12, 2000.
Rustin GJ, Galbraith SM, Anderson H, Stratford M, Folkes LK, Sena L, Gumbrell L, Price PM. Phase I clinical trial of weekly combretastatin A4 phosphate: clinical and pharmacokinetic results. J Clin Oncol. 2003 Aug 1;21(15):2815-22. doi: 10.1200/JCO.2003.05.185. Epub 2003 Jun 13.
Other Identifiers
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CRC-PHASE-I/II-PH1/066
Identifier Type: -
Identifier Source: secondary_id
EU-98066
Identifier Type: -
Identifier Source: secondary_id
CDR0000066805
Identifier Type: -
Identifier Source: org_study_id