Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors

Cancer Clinical Trial

Official title:

A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193570
• Other study ID #: SCRI REFMAL 34
• Secondary ID: 104864652
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: January 22, 2009
• Start date: February 2002
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2009
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Topotecan

• Docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc., GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine maximum tolerated dose of drug combination
Secondary	Response rates