Study of Weekly LOC-paclitaxel Injection for Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01039844
First received: December 23, 2009
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Melanoma
Drug: LOC-paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Weekly LOC-paclitaxel Injection

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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.



Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Luitpold Pharmaceuticals
Investigators
Principal Investigator: Rodabe N. Amaria, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01039844     History of Changes
Other Study ID Numbers: 2009-0432, NCI-2011-01188
Study First Received: December 23, 2009
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 31, 2014