Study of Weekly LOC-paclitaxel Injection for Melanoma

NCT01039844 | Terminated Phase 1

• 2 other identifiers: 2009-0432NCI-2011-01188
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

LOC-paclitaxel Injection; metastatic Melanoma

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD) of LOC-Paclitaxel

  MTD defined as the dose of LOC-paclitaxel at which no more than 2 of 6 patients experience dose limiting toxicity (DLT).

  6 week cycles

• Toxicity of Weekly LOC-Paclitaxel

  Toxicity will be graded according to the NCI Common Toxicity Criteria (CTC), Version 3.0.

  Day 1 of each 6 week cycle

• Tumor Response

  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.

  6 weeks

Study Arms (1)

Weekly LOC-paclitaxel Injection

EXPERIMENTAL

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

Interventions

LOC-paclitaxel DRUG

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.

Weekly LOC-paclitaxel Injection

Eligibility Criteria

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

You may qualify if:

• Patient must have histologically or cytologically confirmed malignant solid tumors.
• Patients must have failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist.
• Patients must have recovered from all acute toxicities from prior therapies, excluding alopecia.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Patients must be \>/= 18 years of age.
• Patients must have adequate liver and renal function as defined by serum creatinine, total bilirubin, AST, and ALT levels within normal limits.
• 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.
• 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.
• Patients must have a life expectancy of at least three months.

You may not qualify if:

• Patients who have therapies available that have demonstrated clinical benefit.
• Patients with known or clinical evidence of central nervous system (CNS) metastases.
• 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.
• 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 1.
• 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 with a known hypersensitivity to CREMOPHOR® and/or paclitaxel.
• 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.
• 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.
• Patients must not have had radiation to \>/= 25% of the bone marrow.
• Patients with Gilbert's Syndrome.
• Patients with known HIV disease or infection.
• Simultaneous participation in another clinical trial of an investigational agent or device.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• American Regent, Inc.: 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

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

Study Officials

• Rodabe N. Amaria, MD

  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: December 23, 2009
• First Posted: December 25, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)