Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors
18 Years
N/A
Both
Cancer, Solid Tumors
Trial Information
Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors
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 found to be eligible to take part in this study, you will be assigned to a dose
level of the study drug combination that is based on when you joined this study. Up to 6
dose levels of the study drug combination will be tested. Three (3) participants will be
enrolled at each dose level. If no intolerable side effects occur in the first group of 3
people, the next 3 people enrolled in the study will receive the same dose of carboplatin
and a higher dose of TAS-106. If this second group has no intolerable side effects, the
next 3 people will receive a higher dose of carboplatin while receiving the same dose of
TAS-106 as the second group. This will continue until the highest safe dose combination is
found.
Study Drug Administration:
A "cycle" in this study is 3 weeks long. On Day 1 of each cycle, you will receive
carboplatin by vein over 60 minutes, followed by TAS-106 by vein over 24 hours.
Study Visits:
On Day 1 of each cycle (+/- 1 day), you will come to the clinic to have the following
procedures performed:
- You will have a complete physical exam, including measurement of vital signs and
weight.
- You will have a neurological exam.
- You will be asked about any drugs you have taken recently and any side effects you may
have experienced. The study doctor may give you drugs to lessen any possible side
effects.
- You will have a performance status evaluation.
- Blood (about 3 teaspoons) and urine will be collected for routine tests.
On Day 1 of Weeks 2 and 3 of each cycle (+/- 3 days), blood (about 3 teaspoons) will be
drawn for routine tests. If your blood cell counts (white blood cells, red blood cells,
and/or platelets) drop to a low level, you may need to have these routine tests repeated
more often than once a week.
At the end of every 2 cycles (+/- 1 week), you will have CT scans, MRI scans, and/or x-rays
to check the status of the disease.
You must stay in the Houston area during Cycle 1. During that time, all blood tests and
other study tests and procedures must be done at MD Anderson. Starting in Cycle 2, if you
prefer, you may have the blood tests at Weeks 2 and 3 of each cycle performed at a medical
laboratory that is close to your home. If you need to have the additional blood cell count
testing performed as well, those blood tests can also be done close to home. All other
study tests and procedures must be done at M. D. Anderson.
Length of Study Participation:
You may continue to stay on the study drugs for as long as you are benefiting. If the
cancer gets worse or you experience intolerable side effects, you will be taken off study.
If you experience side effects that are severe but not intolerable, however, your doctor may
decide that it is necessary to delay your next dose of the study drug combination and/or
lower the dose.
End-of-Study Visit:
When you go off study for any reason, you will have an end-of-study visit with all of the
same tests performed as at your other study visits. You will also have an ECG.
This is an investigational study. Carboplatin is FDA approved and commercially available
for other uses. TAS-106 is not FDA approved or commercially available. The combination of
carboplatin and TAS-106 is not FDA approved or commercially available. At this time, the
combination is being used in research only.
Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.
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 1.5mg/dL, then a calculated creatinine clearance
must be >/=60 mL/min
8. Total bilirubin
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (MTD)
Outcome Time Frame:
With every 3 week cycle
Safety Issue:
Yes
Principal Investigator
Aung Naing, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2007-0623
NCT ID:
NCT00752011
Start Date:
June 2008
Completion Date:
Related Keywords:
- Cancer
- Solid Tumors
- Cancer
- Solid Tumors
- Advanced Cancer
- Carboplatin
- Paraplatin
- TAS-106
- Antitumor Activity
- Biomarkers
- Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
