NCT00193167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 3, 2011

Status Verified

May 1, 2011

Enrollment Period

2.2 years

First QC Date

September 12, 2005

Last Update Submit

May 2, 2011

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • overall response rate

Secondary Outcomes (3)

  • median survival

  • one year survival

  • toxicity

Interventions

TopotecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Anthony Greco, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

January 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 3, 2011

Record last verified: 2011-05

Locations

US(1)