Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I study will characterize the safety, tolerability, and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the combination regimen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Genentech, Inc.; GlaxoSmithKline
• Treatments: Docetaxel; Topotecan

Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Adult > 18 years of age

• ECOG performance status 0 or 1

• Received 3 or less chemotherapy regimens in the metastatic setting

• Adequate bone marrow, liver and kidney function

• Prior brain metastases must be inactive and asymptomatic

• No previous treatment with Topotecan or docetaxel

• Understand the nature of the study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Moderate or severe peripheral neuropathy

• Active concurrent infection or serious underlying medical condition

• Known HIV positivity

• Pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.