Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens.

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

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborator: GlaxoSmithKline
• Treatments: Carboplatin; Topotecan

Criteria

Inclusion Criteria:

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

• Adult patients at least 18 years old

• Advanced solid tumors refractory to conventional therapy

• ECOG performance status must be 0 or 1

• Patients may have received no more than 3 prior chemotherapy regimens

• Adequate bone marrow, liver and kidney function

• Able to 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:

• Active concurrent infections or serious underlying medical conditions

• Known HIV positivity

• Female patients who are pregnant or lactating

• Received both topotecan and carboplatin

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.