Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193167

Enrollment

Registered

2005-09-19

Start date

2004-01-31

Completion date

2006-04-30

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Brief summary

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

Upon determination of eligibility, patients will be receive: * Topotecan

Interventions

DRUGTopotecan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 Please note: There are additional inclusion/

Design outcomes

Primary

Measure	Time frame
overall response rate	—

Secondary

Measure	Time frame
median survival	—
one year survival	—
toxicity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026