Cancer
Conditions
Brief 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.
Interventions
DRUGTopotecan
DRUGCarboplatin
Sponsors
GlaxoSmithKline
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity | — |
| All over response | — |
Countries
United States
Outcome results
None listed