Study of Weekly LOC-paclitaxel Injection for Melanoma
This study has been terminated.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: December 23, 2009
Last updated: May 25, 2016
Last verified: May 2016
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Study of Weekly LOC-paclitaxel Injection
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of LOC-Paclitaxel [ Time Frame: 6 week cycles ] [ Designated as safety issue: Yes ]
MTD defined as the dose of LOC-paclitaxel at which no more than 2 of 6 patients experience dose limiting toxicity (DLT).
- Toxicity of Weekly LOC-Paclitaxel [ Time Frame: Day 1 of each 6 week cycle ] [ Designated as safety issue: Yes ]
Toxicity will be graded according to the NCI Common Toxicity Criteria (CTC), Version 3.0.
- Tumor Response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2016 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039844
|University of Texas MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Rodabe N. Amaria, MD
||M.D. Anderson Cancer Center
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 23, 2009
||May 25, 2016
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 30, 2016
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action