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TerminatedNCT00315211Updated Aug 20, 2018

Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

A Phase 2 interventional study of Intravenous Topotecan and Intravenous Docetaxel in Mediastinal Neoplasms, sponsored by Aultman Health Foundation. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-20.

Sponsored by Aultman Health Foundation · Phase 2, Interventional, and Treatment

Why this study was terminated
Slow Accrual
Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

02

Conditions studied

  • Mediastinal Neoplasms

Keywords

  • Small Cell Lung Cancer Recurrent
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 7 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Aultman Health Foundation is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Other
    Arm A

    Weekly intravenous topotecan with intravenous docetaxel

    Drug: Intravenous Topotecan · Drug: Intravenous Docetaxel

Interventions

  • DrugIntravenous Topotecan

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

    Also known as: Hycamtin

  • DrugIntravenous Docetaxel

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

    Also known as: Taxotere

06

What researchers measure

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

    Time frame: 3 years

07

Study locations

1 site
  • Aultman Hospital
    Canton, Ohio 44710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00315211
Lead sponsor
Aultman Health Foundation
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 18, 2006
Start date
Nov 2004
Primary completion
Jun 2007
Completion
Nov 8, 2007
Last update
Aug 20, 2018

Study contacts

Raza Khan, MD
principal investigator · Aultman Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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