Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

NCT ID: NCT00193167

Last Updated: 2011-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-04-30

Brief Summary

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This non-randomized phase II study is designed to assess the response rate and toxicity of weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic colorectal cancer.

Detailed Description

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Upon determination of eligibility, patients will be receive:

* Topotecan

Conditions

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Colon Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topotecan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

To be included in this study, you must meet the following criteria:

* Metastatic colorectal cancer
* One previous chemotherapy for metastatic disease
* Measurable or evaluable disease
* Able to perform activities of daily living with assistance
* Adequate bone marrow, liver, and kidney function
* All patients must give written informed consent prior to study entry.

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

* Brain or meningeal involvement
* Serious active infection or underlying medical conditions
* Other active neoplasms are ineligible
* Pregnant or lactating
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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SCRI

Principal Investigators

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Anthony Greco, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Tennessee Oncology

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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104864724

Identifier Type: -

Identifier Source: secondary_id

SCRI GI 56

Identifier Type: -

Identifier Source: org_study_id

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