Status:
COMPLETED
Phase I Study of TAS-106 in Combo With Carboplatin
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Cancer
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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. O...
Detailed Description
The Study Drugs: TAS-106 and carboplatin are designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die. Study Drug Dose Level: If you are fou...
Eligibility Criteria
Inclusion
- 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
- Objective evidence or disease recurrence or metastatic disease
- Age \>/= 18 years old at study entry
- Measurable or evaluable disease
- A score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- Hemoglobin \> 9.0 g/dL; Platelet count \>/=100,000/uL; Absolute neutrophil count (ANC) \>/=1500/uL
- Serum creatinine \</=1.5 mg/dL; if \> 1.5mg/dL, then a calculated creatinine clearance must be \>/=60 mL/min
- 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).
- 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.
- Signed written informed consent per institutional and federal regulatory requirements.
Exclusion
- Has known hypersensitivity to carboplatin
- Radiological or clinical evidence of brain involvement or leptomeningeal disease
- Have history of Human Immunodeficiency Virus, hepatitis B, or hepatitis C infection
- \>/=grade 2 peripheral neuropathy
- Women who are pregnant or breast feeding.
- 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
- Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
- Receiving concurrent chemotherapy, investigational agents radiotherapy, or surgery.
- Received radiation therapy to \>30% of bone marrow (e.g., whole of pelvis or half of spine).
- Received any investigational drug within the last 30 days.
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00752011
Start Date
June 1 2008
Last Update
October 18 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030