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Sponsored by: |
University of Maryland |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00771953 |
The primary objective is to determine the anti-tumor activity of the combination of apricoxib + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel (P/DC) or pemetrexed (P/PE) as measured by time to disease progression (TTP)in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).
Condition | Intervention | Phase |
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Lung Cancer Non Small Cell Lung Cancer |
Drug: apricoxib Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients |
Estimated Enrollment: | 130 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Apricoxib plus Docetaxel or Pemetrexed (Treating physician will determine chemotherapy drug as per his usual practice).
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Drug: apricoxib
Oral apricoxib + docetaxel or pemetrexed
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2: Placebo Comparator
Placebo plus Docetaxel or Pemetrexed (Treating physician will determine chemotherapy drug as per his usual practice).
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Drug: Placebo
Placebo + docetaxel or pemetrexed
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Screening for urinary PGE-M suppression may begin during this time period.
United States, Maryland | |
University of Maryland Greenebaum Cancer Center | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Kim Csapo, RN 410-328-7332 ksapo@umm.edu | |
Contact: Richard Zak, RN 410-328-9166 rzak@umm.edu | |
Principal Investigator: Martin Edelman, MD |
Principal Investigator: | Martin J Edelman | University of Maryland Greenebaum Cancer Center |
Responsible Party: | University of Maryland Greenebaum Cancer Center ( Martin J. Edelman, MD ) |
Study ID Numbers: | H-30405, UMGCC 0822 |
Study First Received: | October 10, 2008 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00771953 History of Changes |
Health Authority: | United States: Food and Drug Administration |
apricoxib docetaxel pemetrexed Stage IIIb or Stage IV |
Thoracic Neoplasms Antimetabolites Folic Acid Antagonists Carcinoma Docetaxel Pemetrexed Folic Acid |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Carcinoma |
Docetaxel Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |