MDACC Study Summary 2008-0233 (Archived)

Study Summary
No. 2008-0233:.......Head And Neck......Anne S. Tsao......Thoracic and Head and Neck Med

Study Summary Title



Study Summary Number:	2008-0233

Study Title:	PHASE II STUDY OF TAS-106 IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER REFRACTORY TO PLATINUM BASED CHEMOTHERAPY

Physician

New Patient Referral



Name:	Anne S. Tsao	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Thoracic and Head and Neck Med	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6363 Contact us about clinical trials

General Information



Disease Group:	Head And Neck	Supported By:	Taiho Pharmaceutical Co., Ltd.

Phase of Study:	Phase II	Return Visit:	On Day 1 of each 21-day cycle At the end of every 2 cycles Blood tests on Day 1 of Weeks 2 and 3 of each cycle may be performed close to the participant's home. All other study tests/procedures must be done at MDACC.

Treatment Agents:	TAS-106	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if TAS-106 can help control cancer of the head and neck. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary objective:
To evaluate progression-free survival of TAS-106 in patients with
recurrent or metastatic head and neck cancer (squamous cell carcinoma [SCCHN] or
nasopharyngeal carcinoma [NPC]). Antitumor activity will be evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

Secondary objectives:

To evaluate the antitumor activity

To evaluate overall survival (OS)

To further evaluate the safety profile of TAS-106

To investigate the relationship of TAS-106 plasma levels to safety and efficacy parameters
Exploratory objectives
To investigate the relationship between selected biomarkers and
efficacy and safety outcomes.

Study Status Information



Study Activation / Registration Date:	01/28/2009

IRB Review and Approval Date:	11/13/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	52

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histologically confirmed SCC (without NPC) originating from any site in the head and neck, or histologically confirmed NPC.

2) Patients with recurrent locoregional and/or distant metastatic head and neck (SCCHN or NPC) who are not suitable for local therapy. Eligible patients must be platinum-based chemotherapy refractory defined as; -Progression or recurrence during or within 12 months of receiving a platinum-based regimen as part of primary curative treatment* or for metastatic/recurrent disease. -No intervening systemic therapy allowed except biologics. *Concurrent platinum-based chemotherapy combined with radiotherapy as definitive therapy or post-operation adjuvant or neoadjuvant platinum-based chemotherapy.

3) Objective evidence of disease recurrence or metastatic disease

4) Age 18 >/= years old at study entry

5) Measurable disease according to RECIST guidelines

6) A score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale

7) Hemoglobin > 9.0 g/dL

8) Platelet count >/= 100,000/uL

9) Absolute neutrophil count (ANC) >/= 1500/microliters

10) Serum creatinine </= 1.5 mg/dL; if >1.5 mg/dL, a calculated creatinine clearance must be equal and more than 50 mL/min

11) Total bilirubin </= 1.5 mg/dl

12) Transaminases (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) </= 2 times the upper limit of normal (ULN) (may be </= 5 times ULN if due to metastatic disease in the liver).

13) Fertile men and women, and their partners, must use a medically effective contraception method (spermicide with male or female condoms, cervical sponge, IUD, cervical cap, or diaphragm or oral, implantable, transdermal, or injectable contraceptives) throughout the treatment period and for 30 days after the last dose of study medication. Premenopausal women of reproductive capacity and women less than 12 months after menopause must have a negative pregnancy test documented prior to study entry.

14) Signed written informed consent per institutional and federal regulatory requirements.

Exclusion Criteria:

1) Radiological or clinical evidence of brain involvement or leptomeningeal disease

2) >/= grade 2 peripheral neuropathy

3) Women who are pregnant or breast-feeding.

4) Serious illness or medical condition(s) including but not limited to the following: Congestive heart failure, uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or dysrhythmias, active infection, unstable diabetes mellitus, psychiatric disorder that may interfere with consent and/or protocol compliance

5) Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.

6) Receiving concurrent chemotherapy, investigational agents radiotherapy, or surgery.

7) History of another malignancy in the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix.

8) Received radiation therapy to >30% of bone marrow (e.g., whole of pelvis or half of spine).

9) Received any investigational drug within the last 30 days.

10) Not fully recovered from any prior surgery (at least 3 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.

Links

Registration Number: NCT00737360
Study Information on Clinical Trials Registry (clinicaltrials.gov)