MDACC Study Summary 2005-0259 (Archived)

Study Summary
No. 2005-0259:.......Advanced Cancers......Scott Kopetz......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2005-0259

Study Title:	A Phase I Study of TAS-109 Given by 14-day Continuous Central Intravenous Infusion in Patients with Advanced Solid Tumors (TAS109-0401)

Physician

New Patient Referral



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

Dept:	Gastrointestinal Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Patients must return to MDACC 3 times per week to have infusion bags changed during 2 weeks of infusion.

Treatment Agents:	TAS-109	Home Care:	Study tests and evaluations must be performed at MDACC.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Hospitalization is not required for this study.

Description/
Intervention:

The goal of this clinical research study is to find the highest dose of the new
drug TAS-109 that can be given safely to patients with advanced cancers.
Another goal is to learn about any side effects that may be caused by TAS-109.
Another goal is to find out how TAS-109 is absorbed and distributed in and
excreted (removed) from the body.

The effectiveness of TAS-109 will also be studied on advanced solid tumors.

Study Objectives / Outcomes

Primary Objectives:
To determine the maximum-tolerated dose (MTD)(the dose recommended for Phase II Studies) and the dose-limiting toxicity (DLT) of TAS-109 given by continuous infusion in patients with advanced solid tumors.

To perform Pharmacokinetic (PK) analysis of TAS-109 given by continuous infusion.

Secondary objective:
To assess the anti-tumor activity of TAS-109 given by continuous infusion.

Study Status Information



Study Activation / Registration Date:	07/07/2005

IRB Review and Approval Date:	06/01/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	24

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) Have pathologically-confirmed malignancy that is advanced or locally advanced solid tumor and is refractory to standard therapy or for which conventional therapy is not reliably effective or no effective therapy is available.

2) Be aged >/= 18 years.

3) Have an ECOG Performance Status of 0, 1 or 2.

4) Have adequate clinical laboratory values (i.e., absolute neutrophil count >/= 1.5x10(9)/L, platelets >/= 100x10(9)/L, plasma creatinine </= 1.5 x upper limit of normal (ULN) for the institution, bilirubin </= 1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) </= 2.5 x ULN (transaminase levels can be </= 5.0 x ULN if patient has liver metastases).

5) Have the ability to cooperate with treatment and follow-up schedules.

6) A negative pregnancy test and using at least one form of contraception as approved by the Investigator prior to study entry if a female of childbearing potential or a male patient with a female partner of childbearing potential.

7) Patients may have measurable or non-measurable disease as defined by RECIST criteria.

8) Signed informed consent prior to the start of any study specific procedures.

Exclusion Criteria:

1) Patients that have received previous anticancer chemotherapy, immunotherapy, radiotherapy or any other investigational therapy in the 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry.

2) Patients that have received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.

3) Patients that have any concomitant condition that could compromise the objectives of this study and the patient's compliance.

4) Patients who are a pregnant or lactating women.

5) Patients that have another concurrent primary cancer or patients with a history of another cancer unless the patient has no evidence of disease from the other cancer for 5 years or more. Exceptions to the requirement for no evidence of disease for 5 years or more are adequately treated in situ cervical cancer and basal cell skin cancer.

6) Patients with clinically evident HIV, HBV or HCV infection.

7) Patients that have a current hematologic malignancy.

8) Patients that have a documented or known bleeding disorder.

9) Patients that have requirements for therapeutic anticoagulation that increases INR or aPTT above the normal range (low dose deep vein thrombosis [DVT] or line prophylaxis is allowed).

10) Patients that have known brain, leptomeningeal disease or history of seizure disorder (baseline CT or MRI scan of brain is required only in the case of clinical suspicion of central nervous system metastases).

Links

Registration Number: Not Registered