Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193583
First received: September 12, 2005
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens.


Condition Intervention Phase
Cancer
Drug: Topotecan
Drug: Carboplatin
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 Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for 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:
  • Maximum tolerated dose

Secondary Outcome Measures:
  • Dose limiting toxicity
  • All over response

Estimated Enrollment: 18
Study Start Date: May 2003
Study Completion Date: May 2005
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Topotecan + Carboplatin

In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of topotecan and carboplatin will be utilized (ARM I and ARM II). Patients will be accrued to both treatment arms simultaneously.

  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 patients at least 18 years old
  • Advanced solid tumors refractory to conventional therapy
  • ECOG performance status must be 0 or 1
  • Patients may have received no more than 3 prior chemotherapy regimens
  • Adequate bone marrow, liver and kidney function
  • Able to 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:

  • Active concurrent infections or serious underlying medical conditions
  • Known HIV positivity
  • Female patients who are pregnant or lactating
  • Received both topotecan and carboplatin

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: NCT00193583

Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
GlaxoSmithKline
Investigators
Principal Investigator: Howard A. Burris, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193583     History of Changes
Other Study ID Numbers: SCRI REFMAL 40, 104864-707
Study First Received: September 12, 2005
Last Updated: May 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carboplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014