Hepatic Arterial Infusion of Nab-Paclitaxel in Patients With Metastatic Melanoma in the Liver
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00833807
First received: January 29, 2009
Last updated: February 26, 2013
Last verified: February 2013
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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) [ Time Frame: End of one complete cycle (3 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).
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2014 (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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 The 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., aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT)) 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.
Exclusion Criteria:
- 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
Contacts and Locations
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
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 |
| Study First Received: | January 29, 2009 |
| Last Updated: | February 26, 2013 |
| 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 Liver Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes Pathologic Processes Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013