Phase I Study of Weekly LOC-paclitaxel Injection
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of LOC-Paclitaxel
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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^
- •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
- •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
- •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.
Arms & Interventions
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.
Intervention: LOC-paclitaxel (Drug)
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of LOC-Paclitaxel
Time Frame: 6 week cycles
MTD defined as the dose of LOC-paclitaxel at which no more than 2 of 6 patients experience dose limiting toxicity (DLT).
Tumor Response
Time Frame: 6 weeks
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.
Toxicity of Weekly LOC-Paclitaxel
Time Frame: Day 1 of each 6 week cycle
Toxicity will be graded according to the NCI Common Toxicity Criteria (CTC), Version 3.0.
Secondary Outcomes
No secondary outcomes reported