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Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Primary Purpose

Mediastinal Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous Topotecan
Intravenous Docetaxel
Sponsored by
Aultman Health Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mediastinal Neoplasms focused on measuring Small Cell Lung Cancer Recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Aultman Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm A

Arm Description

Weekly intravenous topotecan with intravenous docetaxel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 17, 2006
Last Updated
August 17, 2018
Sponsor
Aultman Health Foundation
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00315211
Brief Title
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
Official Title
Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
November 8, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aultman Health Foundation
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Neoplasms
Keywords
Small Cell Lung Cancer Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Other
Arm Description
Weekly intravenous topotecan with intravenous docetaxel
Intervention Type
Drug
Intervention Name(s)
Intravenous Topotecan
Other Intervention Name(s)
Hycamtin
Intervention Description
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Intervention Type
Drug
Intervention Name(s)
Intravenous Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
Primary Outcome Measure Information:
Title
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
Description
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raza Khan, MD
Organizational Affiliation
Aultman Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

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