Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: Topotecan Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
- Maximum tolerated dose
- Dose limiting toxicity
- All over response
| Estimated Enrollment: | 18 |
| Study Start Date: | May 2003 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Principal Investigator: | Howard A. Burris, MD | Sarah Cannon Research Institute |
More Information
No publications provided
| Responsible Party: | SCRI Oncology Research Consortium, SCRI |
| ClinicalTrials.gov Identifier: | NCT00193583 History of Changes |
| Other Study ID Numbers: | SCRI REFMAL 40, 104864-707 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carboplatin Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013