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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193570

Enrollment

Registered

2005-09-19

Start date

2002-02-28

Completion date

2009-01-31

Last updated

2009-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGTopotecan

DRUGDocetaxel

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

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/

Design outcomes

Primary

Measure	Time frame
Determine maximum tolerated dose of drug combination	—

Secondary

Measure	Time frame
Response rates	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026