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Phase I Study of Weekly LOC-paclitaxel Injection


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

Phase I Study of Weekly LOC-paclitaxel Injection


The Study Drug:

Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
LOC-paclitaxel is a redesigned version of paclitaxel. Fatty acid is added to paclitaxel,
which may help paclitaxel to stay in the tumor for longer at higher concentrations. This is
the first study using LOC-paclitaxel in humans.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose
level of LOC-paclitaxel based on when you joined this study. Up to 9 dose levels of
LOC-paclitaxel will be tested. Three (3) to 6 participants will be enrolled at each dose
level. The first group of participants will receive the lowest dose level. Each new group
will receive a higher dose than the group before it, if no intolerable side effects were
seen. This will continue until the highest tolerable dose of LOC-paclitaxel is found.

Once the highest tolerable dose of LOC-paclitaxel is found, 12 participants will receive the
study drug at that dose level.

Study Drug Administration:

Each study cycle is 6 weeks.

You will receive LOC-paclitaxel by vein over 1 hour on Days 1, 8, 15, 22, and 29 of each
cycle.

If you experience side effects, your dose of study drug may be lowered.

Study Visits:

On Day 1 of each cycle:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests and to test for tumor
markers.

- If you have melanoma of the head and neck, you will have a CT scan of the neck.

- If you have skin lesions, photographs will be taken of the lesions. Your private areas
will be covered (as much as possible), and a picture of your face will not be taken
unless there are lesions on your face. You will not be able to be identified by any
pictures that may be taken of your lesions.

Once a week:

- Blood (about 1 teaspoon) will be drawn to check your blood cell counts.

- Urine will be collected for routine tests.

- You will be asked if you experienced any side effects.

Every 6 weeks, you will have x-rays and CT scans to check the status of the disease as per
standard of care. If you have had a response to treatment (the disease has disappeared or
the tumors have gotten smaller), the x-rays and CT scans will be repeated again in 4 weeks.
After that, they will be repeated every 6 weeks.

If you experience low blood counts while you are on study, and the doctor thinks it is
severe, you will have a bone marrow biopsy to check for the cause of the low blood counts.To
collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small
amount of bone marrow and bone is withdrawn through a large needle.

If the doctor thinks it is needed, you will have ECGs and extra blood (about 1 teaspoon)
will be drawn.

Any of the procedures listed in this consent form may be performed more frequently, if your
doctor thinks they are needed.

Pharmacokinetic (PK) Testing:

Extra blood will also be drawn for PK testing. PK testing measures the amount of study drug
in the body at different time points. Blood (about 2 teaspoons each time) will be drawn at
the following times:

- On Day 1 of Cycle 1, blood will be drawn before the dose of LOC-paclitaxel, at the end
of the dose, and then 5 more times over the next 11 hours after the dose.

- On Days 2-7 of Cycle 1, blood will be drawn 1 time each day.

- On Days 8, 15, and 22 of Cycle 1, blood will be drawn 1 time each day.

- On Day 29 of Cycle 1, blood will be drawn before the dose, at the end of the dose, and
then 5 more times over the next 11 hours after the dose.

- On Days 30-35 of Cycle 1, blood will be drawn 1 time each day.

Length of Study:

You will be on study for as long as you are benefiting. You will be taken off the study if
you experience intolerable side effects or the disease gets worse.

End-of-Study Visit:

After you are off study, you will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests and to measure tumor
markers.

- You will have CT scans to check the status of the disease.

- If you are having low blood counts, you will have a bone marrow biopsy to check for
side effects.

- If you have skin lesions, photographs will be taken of the lesions.

After you go off study, extra tests may be needed for your safety. This may include routine
blood tests (about 1 tablespoon) and will be continued until you have recovered from any
side effects, which may be 3-4 weeks.

This is an investigational study. LOC-paclitaxel is not FDA approved or commercially
available. LOC-paclitaxel is currently being used for research purposes only.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patient must have histologically or cytologically confirmed malignant solid tumors.

2. Patients must have failed conventional therapy for their cancer or have a malignancy
for which a conventional therapy does not exist.

3. Patients must have recovered from all acute toxicities from prior therapies,
excluding alopecia.

4. Patients must have an ECOG performance status of 0, 1, or 2.

5. Patients must be >/= 18 years of age.

6. Patients must have adequate liver and renal function as defined by serum creatinine,
total bilirubin, AST, and ALT levels within normal limits.

7. Patients must have adequate bone marrow function as defined by a hemoglobin >/=
10g/dL, an absolute neutrophil count of >/= 1,500/mm^3, and platelet count of >/=
100,000/mm^3.

8. Patients must sign an informed consent form indicating that they are aware of the
investigational nature of this study and in keeping with the policies of the
institution.

9. Patients must have a life expectancy of at least three months.

Exclusion Criteria:

1. Patients who have therapies available that have demonstrated clinical benefit.

2. Patients with known or clinical evidence of CNS metastases.

3. Women who are pregnant or nursing and patients (men or women) who are not practicing
an acceptable method of birth control. A negative pregnancy test (urine or serum)
must be documented at baseline for women of childbearing potential. Women may not
breastfeed while on this study.

4. Patients with current active infections requiring anti-infectious treatment (e.g.,
antibiotics, antivirals, or antifungals).

5. Patients with current peripheral neuropathy of any etiology that is greater than
grade 1.

6. Patients with unstable or serious concurrent medical conditions are excluded.
Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent
(within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal
cord compression, superior vena cava syndrome, or any psychiatric disorder that
prohibits obtaining informed consent.

7. Patients with a known hypersensitivity to CREMOPHOR® and/or paclitaxel.

8. Patients must not have had recent major surgery within the past 14 days or large
field radiation therapy or chemotherapy in the last 28 days. If the previous
chemotherapy included nitrosoureas or mitomycin C, this period will be 6 weeks.

9. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy
while on study. Previous palliative radiotherapy is allowed for metastatic disease in
a region that is not part of the disease being measured.

10. Patients must not have had radiation to >/= 25% of the bone marrow.

11. Patients with Gilbert's Syndrome.

12. Patients with known HIV disease or infection.

13. Simultaneous participation in another clinical trial of an investigational agent or
device.

14. Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine,
diltiazem, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine, fluoxetine or
gemfibrozil. Patients taking any of these drugs may qualify for treatment on this
investigational study if they have been off the drug at least for 7 days.

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:

6 week cycles

Safety Issue:

Yes

Principal Investigator

Agop Y. Bedikian, MD, BS

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0432

NCT ID:

NCT01039844

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Melanoma
  • LOC-paclitaxel Injection
  • metastatic Melanoma
  • Melanoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030