NCT00193583CompletedPhase 1
A Phase I Study of Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Patients With Refractory and/or Advanced Solid Tumors
SCRI Development Innovations, LLC1 site in 1 country18 target enrollmentStarted: May 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/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.
Outcomes
Primary Outcomes
Maximum tolerated dose
Secondary Outcomes
- Dose limiting toxicity
- All over response
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid TumorsCancerNCT00193570SCRI Development Innovations, LLC20
Unknown
Phase 1
Reducing Hypoxia in Patients With Coronavirus Disease (COVID-19) Using Topotecan With Standard of CareCOVID-19 Respiratory InfectionNCT05083000National University Hospital, Singapore24
Completed
Phase 1
Phase I Study of Weekly Topotecan in Combination With Sorafenib in Treatment of Relapsed Small Cell Lung CancerSmall Cell CarcinomaLung CancerNCT00466232HealthPartners Institute16
Completed
Phase 1
Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid TumorsSolid TumorsNCT00502892M.D. Anderson Cancer Center2
Terminated
Phase 1
Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical CancerCervix CancerNCT00322920University of Alabama at Birmingham30