COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193570
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 23, 2009
Genentech, Inc.
Information provided by:
SCRI Development Innovations, LLC

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Topotecan Drug: Docetaxel Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors
Study Start Date : February 2002
Actual Primary Completion Date : August 2004
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Determine maximum tolerated dose of drug combination

Secondary Outcome Measures :
  1. Response rates

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193570

Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Layout table for investigator information
Principal Investigator: Howard A. Burris, MD SCRI Development Innovations, LLC
Layout table for additonal information Identifier: NCT00193570    
Other Study ID Numbers: SCRI REFMAL 34
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 23, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors