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

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: TAS-106

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, HKSAR, Hong Kong
    • The Chinese University of Hong Kong, Prince of Wales Hospital
• Singapore
  • Lower Kent Ridge Road, Singapore, 119074
    • National University Hospital
• Taiwan
  • No. 1, Chang-De Street , Taipei, Taiwan, 100
    • National Taiwan University Hospital Department of Oncology
• United States
  • Maryland
    • Orleans Street, Baltimore, Maryland, United States, 21231
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 18, 2008
• First Posted (Estimate): August 19, 2008

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: August 2, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: TAS106-9905