MDACC Study Summary 2007-0623

Study Summary
No. 2007-0623:.......Solid Tumors......Aung Naing......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2007-0623

Study Title:	PHASE I DOSE ESCALATING STUDY OF TAS-106 IN COMBINATION WITH CARBOPLATIN IN PATIENTS WITH SOLID TUMORS

Physician

New Patient Referral



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

Dept:	Investigational Cancer Therapeutics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-0181 Contact us about clinical trials

General Information



Disease Group:	Solid Tumors	Supported By:	Taiho Pharmaceutical Co., Ltd.

Phase of Study:	Phase I	Return Visit:	screening, Days 1 and 2 of Course 1, weekly while on study, end of study

Treatment Agents:	Carboplatin TAS-106	Home Care:	none indicated

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	none indicated


Description/ Intervention:	The goal of this clinical research study is to find the highest safe dose of the combination of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that has spread.

Study Objectives / Outcomes

Primary Objectives
To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin administered by intravenous infusion every 3 weeks.

To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin

Secondary objectives
To assess the antitumor activity of TAS-106 combined with carboplatin

To investigate the relationship between selected biomarkers and efficacy and safety outcomes.

Study Status Information



Study Activation / Registration Date:	06/19/2008

IRB Review and Approval Date:	02/11/2008

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	18

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 or cytologically confirmed diagnosis of a solid tumor. Advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy exists

2) Objective evidence or disease recurrence or metastatic disease

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

4) Measurable or evaluable disease

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

6) Hemoglobin > 9.0 g/dL; Platelet count >/=100,000/uL; Absolute neutrophil count (ANC) >/=1500/uL

7) Serum creatinine </=1.5 mg/dL; if > 1.5mg/dL, then a calculated creatinine clearance must be >/=60 mL/min

8) Total bilirubin </=1.5 mg/dl; ALT </= 2 times the upper limit of normal (ULN) (may be </= 5 times ULN if due to metastatic disease in the liver).

9) 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.

10) Signed written informed consent per institutional and federal regulatory requirements

Exclusion Criteria:

1) Has known hypersensitivity to carboplatin

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

3) Have history of Human Immunodeficiency Virus, hepatitis B, or hepatitis C infection

4) >/=grade 2 peripheral neuropathy

5) Women who are pregnant or breast feeding.

6) Serious illness or medical condition(s) including but not limited to the following: a) Congestive heart failure or uncontrolled angina pectoris. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or dysrhythmias. b) Active infection. c) Unstable diabetes mellitus. d) Psychiatric disorder that may interfere with consent and/or protocol compliance

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

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

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

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

11) Not fully recovered from any prior surgery (at least 4 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: NCT00752011
Study Information on Clinical Trials Registry (clinicaltrials.gov)