TerminatedNCT01039844Updated Oct 27, 2016

Study of Weekly LOC-paclitaxel Injection for Melanoma

A Phase 1 interventional study of LOC-paclitaxel in Melanoma, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment

Why this study was terminated

Poor Accrual

Phase: Phase 1
Study type: Interventional
Enrollment: 37
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The goal of this clinical research study is to find the highest tolerable dose of LOC-paclitaxel when given to patients with metastatic melanoma. The safety of this drug and if it can control the disease is also being studied.

Read the detailed description

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.

Conditions studied

Melanoma

Browse trials for

Melanoma 3,006

Keywords

LOC-paclitaxel Injection
metastatic Melanoma

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 37 is close to the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patient must have histologically or cytologically confirmed malignant solid tumors.
Patients must have failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist.
Patients must have recovered from all acute toxicities from prior therapies, excluding alopecia.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Patients must be >/= 18 years of age.
Patients must have adequate liver and renal function as defined by serum creatinine, total bilirubin, AST, and ALT levels within normal limits.
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.
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.
Patients must have a life expectancy of at least three months.

Exclusion criteria

Exclusion Criteria:

Patients who have therapies available that have demonstrated clinical benefit.
Patients with known or clinical evidence of central nervous system (CNS) metastases.
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.
Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
Patients with current peripheral neuropathy of any etiology that is greater than grade 1.
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.
Patients with a known hypersensitivity to CREMOPHOR® and/or paclitaxel.
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.
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.
Patients must not have had radiation to >/= 25% of the bone marrow.
Patients with Gilbert's Syndrome.
Patients with known HIV disease or infection.
Simultaneous participation in another clinical trial of an investigational agent or device.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
Weekly LOC-paclitaxel Injection
LOC-paclitaxel IV by a 1 hour infusion on Day 1, 8, 15, 22 and 29; repeated every 42 days (6 weeks) per cycle.
Drug: LOC-paclitaxel

Interventions

DrugLOC-paclitaxel
Phase I Starting Dose: 100 mg/m\^2 IV (intravenously) 1 hour infusion on Day 1, 8, 15, 22 and 29; and repeated every 42 days (6 weeks) per cycle. Phase II Starting Dose: Maximum tolerated dose from Phase I.

What researchers measure

Primary outcomes

Maximum Tolerated Dose (MTD) of LOC-Paclitaxel
MTD defined as the dose of LOC-paclitaxel at which no more than 2 of 6 patients experience dose limiting toxicity (DLT).
Time frame: 6 week cycles
Toxicity of Weekly LOC-Paclitaxel
Toxicity will be graded according to the NCI Common Toxicity Criteria (CTC), Version 3.0.
Time frame: Day 1 of each 6 week cycle
Tumor Response
The Response Evaluation Criteria in Solid Tumors (RECIST) used to assess tumor response to treatment in this study. Complete Response (CR): disappearance of all target lesions determined by two consecutive observations not less than four weeks apart. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
Time frame: 6 weeks

Study locations

1 site

University of Texas MD Anderson Cancer Center
Houston, Texas 77030, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01039844
Lead sponsor: M.D. Anderson Cancer Center
Collaborators: American Regent, Inc.
Responsible party: Sponsor
First posted: Dec 25, 2009
Start date: Dec 2009
Primary completion: Feb 2016
Completion: Feb 2016
Last update: Oct 27, 2016

Study contacts

Rodabe N. Amaria, MD

principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Melanoma→

Other studies from this sponsor

M.D. Anderson Cancer Center

Start the discussion