Phase II Study of TAS-106 to Treat Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00737360|
Recruitment Status : Terminated
First Posted : August 19, 2008
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: TAS-106||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy|
|Study Start Date :||August 2008|
|Primary Completion Date :||June 2011|
|Study Completion Date :||February 2012|
6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
- Progression Free Survival(PFS) [ Time Frame: From the date of registration until the earliest date of documented disease progression, death, or censoring event. ]PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
- Antitumor Activity [ Time Frame: Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter. ]Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR.", or similar text that was as accurate and appropriate.
- Overall Survival [ Time Frame: 12 months after enrollment of the last patient ]Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
- Safety [ Time Frame: Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication. ]Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737360
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Orleans Street, Baltimore, Maryland, United States, 21231|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|The Chinese University of Hong Kong, Prince of Wales Hospital|
|Shatin, HKSAR, Hong Kong|
|National University Hospital|
|Lower Kent Ridge Road, Singapore, 119074|
|National Taiwan University Hospital Department of Oncology|
|No. 1, Chang-De Street , Taipei, Taiwan, 100|