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A Phase I Study of Topotecan in Combination With Docetaxel in 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 Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors


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.


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.

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:

Determine maximum tolerated dose of drug combination

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 34

NCT ID:

NCT00193570

Start Date:

February 2002

Completion Date:

January 2009

Related Keywords:

  • Cancer

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