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

Phase 2TerminatedNCT00737360

Taiho Pharmaceutical Co., Ltd.27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

TAS-106DRUG

6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Orleans Street, Baltimore, Maryland, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

The Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hksar, Hong Kong

National University Hospital

Lower Kent Ridge Road, Singapore

Outcomes

Primary Outcomes

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.

Time frame: From the date of registration until the earliest date of documented disease progression, death, or censoring event.

Secondary Outcomes

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.

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.

Overall Survival

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

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.

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.

Data from ClinicalTrials.gov

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