Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
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Purpose
This phase I study will characterize the safety, tolerability, and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the combination regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: Topotecan Drug: Docetaxel |
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 Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors |
- Determine maximum tolerated dose of drug combination
- Response rates
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2002 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Upon determination of eligibility, patients will be receive:
- Docetaxel + Topotecan
In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of Topotecan and docetaxel will be utilized.
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 > 18 years of age
- ECOG performance status 0 or 1
- Received 3 or less chemotherapy regimens in the metastatic setting
- Adequate bone marrow, liver and kidney function
- Prior brain metastases must be inactive and asymptomatic
- No previous treatment with Topotecan or docetaxel
- 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:
- Moderate or severe peripheral neuropathy
- Active concurrent infection or serious underlying medical condition
- Known HIV positivity
- Pregnant or lactating
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00193570 History of Changes |
| Other Study ID Numbers: | SCRI REFMAL 34, 104864652 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 22, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Topotecan Docetaxel Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013