Chemotherapy in Treating Patients With Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003698
• Lead Sponsor: University of Glasgow

Brief 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.

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 1999-11-01
• Study Completion: 2003-12
• Study First Submitted QC: 2004-05-19
• Study First Posted: 2004-05-20
• Status Verified: 2008-02
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Mount Vernon Hospital; 🇬🇧 Northwood, England, United Kingdom