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Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for 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: NCT00193583
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 4, 2011
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Drug: Topotecan Drug: Carboplatin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2003
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Maximum tolerated dose

Secondary Outcome Measures :
  1. Dose limiting toxicity
  2. All over response

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.

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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 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.

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): NCT00193583

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United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
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Principal Investigator: Howard A. Burris, MD SCRI Development Innovations, LLC
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Responsible Party: SCRI Oncology Research Consortium, SCRI Identifier: NCT00193583    
Other Study ID Numbers: SCRI REFMAL 40
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action