Chemotherapy in Treating Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003698|
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : December 19, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating patients who have advanced malignant solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: fosbretabulin disodium||Phase 1|
OBJECTIVES: I. Determine the toxicity profile, including dose limiting toxicity, and maximum tolerated dose (MTD) of combretastatin A4 phosphate in patients with advanced solid malignant tumors. II. Determine the pharmacokinetics of combretastatin A4 phosphate. III. Assess the effects of combretastatin A4 phosphate on tumor blood flow using PET and MRI scanning techniques, and establish the dose at which these effects occur. IV. Recommend a dose of combretastatin A4 phosphate for phase II evaluation based on tumor blood flow effect and the MTD. V. Evaluate possible antitumor effects of this regimen in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Official Title:||A Phase I Trial of Combretastatin A4 Phosphate in Patients With Solid Tumours Given by Weekly Intravenous Infusion|
|Study Start Date :||July 1998|
|Actual Study Completion Date :||December 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003698
|Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Study Chair:||Gordon J.S. Rustin, MD||Mount Vernon Cancer Centre at Mount Vernon Hospital|