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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737360
• Other study ID #: TAS106-9905
• Status: Terminated
• Phase: Phase 2
• First received: August 18, 2008
• Last updated: August 2, 2012
• Start date: August 2008
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Hong Kong,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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	No
Secondary	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.	Yes