Study of Weekly LOC-paclitaxel Injection for Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01039844
Recruitment Status : Terminated (Poor Accrual)
First Posted : December 25, 2009
Last Update Posted : October 27, 2016
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: LOC-paclitaxel Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Weekly LOC-paclitaxel Injection
Study Start Date : December 2009
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
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

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.

Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Eastern Cooperative Oncology Group (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 central nervous system (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01039844

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Luitpold Pharmaceuticals
Principal Investigator: Rodabe N. Amaria, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01039844     History of Changes
Other Study ID Numbers: 2009-0432
NCI-2011-01188 ( Registry Identifier: NCI CTRP )
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by M.D. Anderson Cancer Center:
LOC-paclitaxel Injection
metastatic Melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action