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

NCT00833807 | Completed Phase 1

• 2 other identifiers: 2006-0603NCI-2010-01023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma; Liver Metastasis

Keywords

Melanoma; Metastatic Melanoma to the Liver; Liver metastasis; Nab-paclitaxel; Abraxane; Paclitaxel (protein-bound); intraarterial intrahepatic administration; Hepatic Artery; Hepatic Arterial Infusion; Hepatic Administration

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Nab-Paclitaxel

  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).

  6 weeks

Secondary Outcomes (1)

• Survival Rate

  After 3, 21 day cycles

Study Arms (1)

Nab-paclitaxel (Abraxane)

EXPERIMENTAL

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)

Interventions

Nab-Paclitaxel (Abraxane) DRUG

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.

Also known as: Nab-Paclitaxel (Hepatic administration), Paclitaxel, Paclitaxel (protein-bound)

Nab-paclitaxel (Abraxane)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologic confirmation of malignant melanoma, and documented metastatic disease.
• 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.
• 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.
• 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.
• 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.
• Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
• Patients must be \>/= 18 years of age. The safety of NAB-Paclitaxel has not been studied in younger patients.
• 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.
• Life expectancy of at least 3 months.
• 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.

You may not qualify if:

• Patients who have received prior systemic chemotherapy with regimens including taxanes.
• Patients with history of central nervous system (CNS) metastasis prior to registering to this study.
• 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.
• 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 one.
• 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 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.
• Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
• Known HIV disease or infection.
• Patients with ascites are not eligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Study Officials

• Agop Y. Bedikian, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: February 2, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

US (1)