NCT00315211

Brief Summary

The purposes of this study are:

  • To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
  • To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2007

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

2.6 years

First QC Date

April 17, 2006

Last Update Submit

August 17, 2018

Conditions

Mediastinal Neoplasms

Keywords

Small Cell Lung Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

  • To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel

    To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel

    3 years

Study Arms (1)

Arm A

OTHER

Weekly intravenous topotecan with intravenous docetaxel

Drug: Intravenous TopotecanDrug: Intravenous Docetaxel

Interventions

Intravenous TopotecanDRUG

Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days

Also known as: Hycamtin
Arm A
Intravenous DocetaxelDRUG

Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 \& 8 of a 21 day cycle

Also known as: Taxotere
Arm A

Eligibility Criteria

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

You may qualify if:

  • Recurred greater than 90 days after initial treatment
  • At least 1 measurable lesion
  • Only 1 prior chemotherapy
  • Must be over 18 years of age
  • ECOG performance status of 0 - 2
  • Adequate hematologic, renal, and hepatic function

You may not qualify if:

  • No prior use of topotecan, docetaxel, or irinotecan
  • No symptomatic brain metastases
  • History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
  • No prior investigational agents within 1 month prior
  • Lung cancer of mixed histology
  • Known uncontrolled seizure disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aultman Hospital

Canton, Ohio, 44710, United States

Location

MeSH Terms

Conditions

Mediastinal Neoplasms

Interventions

TopotecanDocetaxel

Condition Hierarchy (Ancestors)

Thoracic NeoplasmsNeoplasms by SiteNeoplasmsMediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Raza Khan, MD

    Aultman Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2006

First Posted

April 18, 2006

Study Start

November 1, 2004

Primary Completion

June 1, 2007

Study Completion

November 8, 2007

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

US(1)