NCT00193245

Brief Summary

In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_2 lung-cancer

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

November 1, 2000

Completed
4.9 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
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 28, 2010

Status Verified

January 1, 2009

Enrollment Period

4.9 years

First QC Date

September 12, 2005

Last Update Submit

June 24, 2010

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

Secondary Outcomes (3)

  • Time to Progression

  • Overall survival

  • Overall toxicity

Interventions

TopotecanDRUG
DocetaxelDRUG

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:
  • Relapsed or Progressive Disease
  • Stage IIIB (not candidate for combined modality) or IV
  • No more than one prior chemotherapy regimen
  • Able to perform activities of daily living without assistance
  • Measurable disease outside of radiation port
  • Adequate bone marrow, liver and kidney function
  • Must understand study and sign informed consent prior to enrollment

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Prior treatment with Topotecan or Docetaxel
  • Uncontrolled brain metastases
  • Moderate peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Related Publications (1)

  • Jones S, Thompson D, Barton J, Patton J, Shipley D, Greco FA, Spigel D, Infante J, Burris HA 3rd. A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer. Clin Lung Cancer. 2008 May;9(3):154-9. doi: 10.3816/CLC.2008.n.023.

    PMID: 18621625RESULT

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

TopotecanDocetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Howard A. Burris, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

November 1, 2000

Primary Completion

October 1, 2005

Study Completion

January 1, 2009

Last Updated

June 28, 2010

Record last verified: 2009-01

Locations

US(1)