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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: TAS-106


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: TAS-106<br>* 6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival(PFS) | PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event. | From the date of registration until the earliest date of documented disease progression, death, or censoring event. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor Activity | 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. | 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. | 
| Overall Survival | Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011. | 12 months after enrollment of the last patient | 
| Safety | 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. | 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. |