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

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01004601
First received: October 27, 2009
Last updated: October 28, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Non Small Cell Lung Cancer
Drug: docetaxel
Drug: pemetrexed

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: at least 3 cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PFS-progression free survival [ Time Frame: the time from the first cycle of chemotherapy to documented progression, or death from any cause ] [ Designated as safety issue: Yes ]
  • OS-overall survival [ Time Frame: from the start date of the treatment to death or to the last follow-up visit ] [ Designated as safety issue: Yes ]

Enrollment: 179
Study Start Date: March 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low dose docetaxel
Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)
Drug: docetaxel
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.
Active Comparator: Pemetrexed
Pemetrexed (500 mg/m2 every 3 weeks)
Drug: pemetrexed
patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004601

Locations
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 10507
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Han-Pin Kuo Chang Gung Memorial Hospital
  More Information

Publications:

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01004601     History of Changes
Other Study ID Numbers: 98-2587B
Study First Received: October 27, 2009
Last Updated: October 28, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
pretreated failure advanced stage IIIb/IV NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 22, 2014