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Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
docetaxel
pemetrexed
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring pretreated failure advanced stage IIIb/IV NSCLC

Eligibility Criteria

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

Inclusion Criteria:

  • stage IIIb or IV NSCLC
  • previous treatment with chemotherapy or tyrosin kinase inhibitor
  • performance status less than 2

Exclusion Criteria:

  • age less 18 years
  • pregnancy
  • performance status 3-4

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

low dose docetaxel

Pemetrexed

Arm Description

Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)

Pemetrexed (500 mg/m2 every 3 weeks)

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

PFS-progression free survival
OS-overall survival

Full Information

First Posted
October 27, 2009
Last Updated
October 28, 2009
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01004601
Brief Title
Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer
Official Title
Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75 mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced NSCLC.
Detailed Description
We have been following a schedule of weekly low dose docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks; 60 mg/m2 accumulated dose for each cycle) at our hospital in an effort to achieve better tolerability. We therefore performed an exploratory study, by statistical analyses, to investigate the efficacy and toxicity of such a low dose docetaxel schedule compared to that of pemetrexed in patients with NSCLC who have failed previous chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
pretreated failure advanced stage IIIb/IV NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose docetaxel
Arm Type
Active Comparator
Arm Description
Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)
Arm Title
Pemetrexed
Arm Type
Active Comparator
Arm Description
Pemetrexed (500 mg/m2 every 3 weeks)
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
patients at one university-affiliated hospital received low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)following failure of previous treatment stage IIIb/IV NSCLC.
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV NSCLC.
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
at least 3 cycles
Secondary Outcome Measure Information:
Title
PFS-progression free survival
Time Frame
the time from the first cycle of chemotherapy to documented progression, or death from any cause
Title
OS-overall survival
Time Frame
from the start date of the treatment to death or to the last follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stage IIIb or IV NSCLC previous treatment with chemotherapy or tyrosin kinase inhibitor performance status less than 2 Exclusion Criteria: age less 18 years pregnancy performance status 3-4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Pin Kuo
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15117980
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer

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