Clinical trial · Interventional
Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors
NCT00193570CI-TRIAL-00001927completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine maximum tolerated dose of drug combination
Secondary outcomes (1)
- measure
- Response rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.