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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-05-31

Brief Summary

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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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Detailed Description

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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

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topotecan

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No