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

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ClinicalTrials.gov Identifier: NCT01004601
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : October 30, 2009
Information provided by:

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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Drug: docetaxel Drug: pemetrexed

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan
Study Start Date : March 2005
Primary Completion Date : October 2008
Study Completion Date : October 2008

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: at least 3 cycles ]

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004601

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


Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01004601     History of Changes
Other Study ID Numbers: 98-2587B
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors