Back to resultsPhase II Study of TAS-106 to Treat Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAS-106
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- University of Texas MD Anderson Cancer Center
- The Chinese University of Hong Kong, Prince of Wales Hospital
- National University Hospital
- National Taiwan University Hospital Department of Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall Survival
Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
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.
Full Information
NCT ID
NCT00737360
First Posted
August 18, 2008
Last Updated
August 2, 2012
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00737360
Brief Title
Phase II Study of TAS-106 to Treat Head and Neck Cancer
Official Title
Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TAS-106
Intervention Description
6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Progression Free Survival(PFS)
Description
PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
Time Frame
From the date of registration until the earliest date of documented disease progression, death, or censoring event.
Secondary Outcome Measure Information:
Title
Antitumor Activity
Description
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.
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.
Title
Overall Survival
Description
Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
Time Frame
12 months after enrollment of the last patient
Title
Safety
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Orleans Street, Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Chinese University of Hong Kong, Prince of Wales Hospital
City
Shatin, HKSAR
Country
Hong Kong
Facility Name
National University Hospital
City
Lower Kent Ridge Road
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Taiwan University Hospital Department of Oncology
City
No. 1, Chang-De Street , Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of TAS-106 to Treat Head and Neck Cancer
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