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

SCRI Development Innovations

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: Carboplatin

Drug: Topotecan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193583

SCRI REFMAL 40

104864-707

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.