NCT00003698

Chemotherapy in Treating Patients With Solid Tumors

A Phase I Trial of Combretastatin A4 Phosphate in Patients With Solid Tumours Given by Weekly Intravenous Infusion

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Glasgow · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	fosbretabulin disodium

Timeline

• Start date: 1998-07-01
• Completion: 2003-12-01
• First posted: 2004-05-20
• Last updated: 2013-12-19

Locations

1 site across 1 country: United Kingdom