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

Completed · Phase 1

Conditions studied: Cancer

In brief

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.

Key facts

Study ID: NCT00193583
Run by: SCRI Development Innovations, LLC
People needed: 18
Starts: 2003-05-01
Expected to finish: 2005-05-01
Last updated by the study team: 2011-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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