Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors - Full Text View

Sponsors and Collaborators:	Sarah Cannon Research Institute GlaxoSmithKline Genentech
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193570

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Determine maximum tolerated dose of drug combination

Secondary Outcome Measures:

Response rates

Estimated Enrollment:	20
Study Start Date:	February 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193570

Sponsors and Collaborators

Sarah Cannon Research Institute

GlaxoSmithKline

Genentech

Investigators

Principal Investigator:

Howard A. Burris, MD

Sarah Cannon Research Institute

More Information

Study ID Numbers:	SCRI REFMAL 34, 104864652
Study First Received:	September 12, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00193570
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Topotecan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009