Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
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|ClinicalTrials.gov Identifier: NCT00423150|
Recruitment Status : Terminated
First Posted : January 18, 2007
Results First Posted : July 5, 2010
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasm Head and Neck Neoplasm Carcinoma, Non-Small-Cell Lung Esophageal Neoplasm||Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 26, 2007|
|Actual Primary Completion Date :||June 11, 2009|
|Actual Study Completion Date :||June 11, 2009|
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.
Other Name: Temodal, TMZ, SCH 52365
- Tumor Responses (Complete and Partial Response) [ Time Frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first ]
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.