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

NCT ID: NCT00193570

Last Updated: 2009-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2009-01-31

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Topotecan

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Principal Investigators

Howard A. Burris, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Other Identifiers

104864652

Identifier Type: -

Identifier Source: secondary_id

SCRI REFMAL 34

Identifier Type: -

Identifier Source: org_study_id