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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Genentech
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193570
First received: September 12, 2005
Last updated: January 22, 2009
Last verified: January 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Determine maximum tolerated dose of drug combination

Secondary Outcome Measures:
  • Response rates

Estimated Enrollment: 20
Study Start Date: February 2002
Study Completion Date: January 2009
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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

Sponsors and Collaborators
SCRI Development Innovations, LLC
GlaxoSmithKline
Genentech
Investigators
Principal Investigator: Howard A. Burris, MD SCRI Development Innovations, LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00193570     History of Changes
Other Study ID Numbers: SCRI REFMAL 34, 104864652
Study First Received: September 12, 2005
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Docetaxel
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014