NCT00193583

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

A Phase I Study of Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Patients With Refractory and/or Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (planned)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Upon determination of eligibility, patients will be receive: * Topotecan + Carboplatin In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of topotecan and carboplatin will be utilized (ARM I and ARM II). Patients will be accrued to both treatment arms simultaneously.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Topotecan
DRUG	Carboplatin

Timeline

• Start date: 2003-05-01
• Primary completion: 2004-05-01
• Completion: 2005-05-01
• First posted: 2005-09-19
• Last updated: 2011-05-04

Locations

1 site across 1 country: United States