Phase II Study of TAS-106 to Treat Head and Neck Cancer

Phase 2

Terminated

Brief Summary: The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.

Recruitment & Eligibility

Inclusion Criteria

Age 18 ≤ years old at study entry
Histologically confirmed head and neck carcinoma
Received prior platinum based regimen and developed disease progression or recurrence
Measurable disease according to RECIST guidelines

Exclusion Criteria

Radiological or clinical evidence of brain involvement or leptomeningeal disease
≥ grade 2 peripheral neuropathy
History of another malignancy

Arm && Interventions

Group	Intervention	Description
1	TAS-106	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival(PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Antitumor Activity	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	12 months after enrollment of the last patient	Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
Safety	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.

Locations (5): Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
🇺🇸
Orleans Street, Baltimore, Maryland, United States
National University Hospital
🇸🇬
Lower Kent Ridge Road, Singapore
National Taiwan University Hospital Department of Oncology
🇨🇳
No. 1, Chang-De Street , Taipei, Taiwan
University of Texas MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
The Chinese University of Hong Kong, Prince of Wales Hospital
🇭🇰
Shatin, HKSAR, Hong Kong