EPO906 Therapy in Patients With Advanced Melanoma

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: epothilone b

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • New York
    • Bronx, New York, United States, 10466-2697
      • Comprehensive Cancer Center@ Our Lady if Mercy Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Oncology, Inc.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

The following patients may be eligible for this study:

• Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
• Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
• Must have a life expectancy of greater than three (3) months
• Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed > 4 weeks prior to treatment
• Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to treatment
• Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed).

Exclusion Criteria

The following patients are not eligible for this study:

• Patients with choroidal ocular melanoma
• Patients with symptomatic CNS metastases or leptomeningeal involvement
• Patients with renal or hepatic dysfunction
• Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
• Patients with severe cardiac insufficiency
• Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
• Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study
• Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy)
• Patients receiving chemotherapy within the last four weeks
• History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
• Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
• HIV+ patients
• Pregnant or lactating females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPO906	Drug: epothilone b; intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off; Other Names: Patupilone, EPO906

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response (complete response (CR), partial response (PR), stable disease (SD))	Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.	at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma	For biomarker development	prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment
Number and percentage of patients with Adverse events	Safety and tolerabilty of EPO906: Safety assessments consisted of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance status.	as necessary
Objective response rate (ORR)		at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Time to disease progression (TTP)		at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Overall Survival (OS)		from the date of the first dose of treatment to date of death from any cause, or the last date the patient is known to be alive

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): May 1, 2003

Study Registration Dates

• First Submitted: May 2, 2002
• First Submitted That Met QC Criteria: May 2, 2002
• First Posted (Estimate): May 3, 2002

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: cancer; tumour; metastatic; melanoma; intravenous; tumor; malignant; epothilone
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilones; Epothilone B
• Other Study ID Numbers: CEPO906A2206