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Completed

NCT Number: NCT00193583

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topotecan

Drug

carboplatin

Drug

Primary outcomes

  1. Maximum tolerated dose

Secondary outcomes

  1. Dose limiting toxicity

  2. All over response

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.