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A Phase I Study of Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Patients With Refractory and/or Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase I Study of Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Patients With Refractory and/or Advanced Solid Tumors


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Principal Investigator

Howard A. Burris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI REFMAL 40

NCT ID:

NCT00193583

Start Date:

May 2003

Completion Date:

May 2005

Related Keywords:

  • Cancer

Name

Location

Tennessee Oncology, PLLCClarksville, Tennessee  37043