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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00737360
First received: August 18, 2008
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: TAS-106
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Progression Free Survival(PFS) [ Time Frame: From the date of registration until the earliest date of documented disease progression, death, or censoring event. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 27
Study Start Date: August 2008
Study Completion Date: February 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737360

Locations
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
Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, HKSAR, Hong Kong
Singapore
National University Hospital
Lower Kent Ridge Road, Singapore, 119074
Taiwan
National Taiwan University Hospital Department of Oncology
No. 1, Chang-De Street , Taipei, Taiwan, 100
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00737360     History of Changes
Other Study ID Numbers: TAS106-9905
Study First Received: August 18, 2008
Results First Received: April 20, 2012
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014