A Phase 2 Study of Temozolomide (SCH 52365) in Subjects With Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter
Sponsor study identifier
interventional
86
0 countries
N/A
Study Start
January 26, 2007
Actual (reported)Primary Completion
June 11, 2009
Actual (reported)Study Completion
June 11, 2009
Actual (reported)This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 11, 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2006
Actual (reported)January 18, 2007
Actual (reported)January 26, 2007
Actual (reported)June 11, 2009
Actual (reported)June 11, 2009
Actual (reported)July 5, 2010
Actual (reported)Tumor Responses (Complete and Partial Response)
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.
Hochhauser D, Glynne-Jones R, Potter V, Gravalos C, Doyle TJ, Pathiraja K, Zhang Q, Zhang L, Sausville EA. A phase II study of temozolomide in patients with advanced aerodigestive tract and colorectal cancers and methylation of the O6-methylguanine-DNA methyltransferase promoter. Mol Cancer Ther. 2013 May;12(5):809-18. doi: 10.1158/1535-7163.MCT-12-0710. Epub 2013 Feb 26.
Due to low response rate for colorectal cancer in interim analyses, low enrollment in head \& neck and non-small cell lung cancer groups due to low methylation rates, and low overall response rate in esophageal cancer group, the study was terminated.
86 participants (actual enrollment reported by the registry).
First Submitted
November 30, 2006
First Posted
January 18, 2007
Study Start
January 26, 2007
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 11, 2009
Actual (reported)Study Completion
June 11, 2009
Actual (reported)Last Updated
June 8, 2017
Results First Posted
July 5, 2010
Record last verified: 2017-05
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
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Source: ClinicalTrials.gov.
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