Hepatic Arterial Infusion of Nab-Paclitaxel in Patients With Metastatic Melanoma in the Liver

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00833807
First received: January 29, 2009
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of this drug will also be studied.


Condition Intervention Phase
Melanoma
Liver Metastasis
Drug: Nab-Paclitaxel (Abraxane)
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 Hepatic Arterial Infusion Of Nab-Paclitaxel (Abraxane®) In Patients With Metastatic Melanoma In The Liver

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Nab-Paclitaxel [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The MTD of nab-paclitaxel in participants with metastatic melanoma, previously untreated with systemic chemotherapy, defined as the dose level prior to that resulting in dose limiting toxicity (DLT) (ie., the highest dose level of nab-paclitaxel at which 0 out of 3 patients or 1 out of 6 patients experience DLT).


Secondary Outcome Measures:
  • Survival Rate [ Time Frame: After 3, 21 day cycles ] [ Designated as safety issue: No ]
    Overall survival (OS) defined as time from first date of study treatment until date of subject death from any cause. For subjects who have not died, survival data censored at subjects' last known alive date. Kaplan-Meier method used to estimate distribution and median OS for subjects treated at the MTD level. Progression-free survival (PFS) defined as time from first date of study treatment to documented disease progression, or to death from any cause within 30 days of last dose of study treatment, whichever occurs earlier. Disease response including indicator lesions in the liver assessed by investigator according to RECIST.


Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nab-paclitaxel (Abraxane)

Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days.

Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days.

Drug: Nab-Paclitaxel (Abraxane)

Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days.

Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days.

Other Names:
  • Nab-Paclitaxel (Hepatic administration)
  • Paclitaxel
  • Paclitaxel (protein-bound)

  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. Patients must have histologic confirmation of malignant melanoma, and documented metastatic disease.
  2. Patients must have at least one clearly measurable metastatic lesion in the liver that is more than 2cm in the largest dimension. Indicator lesions at least 2cm are chosen primarily to have changes in tumor measurement more accurately reflective of effect of therapy, or lack of it.
  3. Patients must not have received prior systemic chemotherapy with regimens including taxanes. Prior adjuvant treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression in the liver.
  4. At least 4 weeks (28 days) since any prior immunotherapy, cytokine, biologic, vaccine therapy or tumor embolization in the liver and patients should have progressed during therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
  5. At least 4 weeks (28 days) since prior radiotherapy (if radiation therapy field covering > 20% of the bone marrow containing skeletal structures) and prior adjuvant therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
  6. Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
  7. Patients must have ECOG performance status of 0 - 2.
  8. Patients must be >/= 18 years of age. The safety of NAB-Paclitaxel has not been studied in younger patients.
  9. Patients must have normal serum total bilirubin level, transaminase levels (i.e., ALT and AST) no higher than 2.5 times the institution's upper normal limits. Patients must have adequate renal function: creatinine </= 1.5 mg/dL Patients must have adequate bone marrow function as defined by an absolute neutrophil count >/= 1,500/mm^3, platelet count >/= 100,000/mm^3 and hemoglobin >/= 9.0g/dL.
  10. Life expectancy of at least 3 months.
  11. 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.

Exclusion Criteria:

  1. Patients who have received prior systemic chemotherapy with regimens including taxanes.
  2. Patients with history of CNS metastasis prior to registering to this study.
  3. Patients who are pregnant or nursing and patients 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. Patients may not breast-feed 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 one.
  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 must not have had major surgery including node dissection, resection of melanoma metastatic to an organ or other surgical procedures that require hospitalization and administration of general anesthesia within the past 14 days.
  8. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
  9. Known HIV disease or infection.
  10. Patients with ascites are not eligible.
  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: NCT00833807

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Agop Y. Bedikian, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00833807     History of Changes
Other Study ID Numbers: 2006-0603, NCI-2010-01023
Study First Received: January 29, 2009
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Melanoma
Metastatic Melanoma to the Liver
Liver metastasis
Nab-paclitaxel
Abraxane
Paclitaxel (protein-bound)
intraarterial intrahepatic administration
Hepatic Artery
Hepatic Arterial Infusion
Hepatic Administration

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
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 September 18, 2014