EPO906 Therapy in Patients With Advanced Melanoma

NCT00035165 | Completed Phase 2

• 1 other identifier: CEPO906A2206
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Melanoma

Keywords

melanoma; cancer; tumor; tumour; malignant; metastatic; intravenous; epothilone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number and percentage of patients with Adverse events

  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

• Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma

  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

Study Arms (1)

EPO906

EXPERIMENTAL

Drug: epothilone b

Interventions

epothilone b DRUG

intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off

Also known as: Patupilone, EPO906

EPO906

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

University of Colorado

Aurora, Colorado, 80045, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Comprehensive Cancer Center@ Our Lady if Mercy Medical Center

The Bronx, New York, 10466-2697, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oklahoma Oncology, Inc.

Tulsa, Oklahoma, 74104, United States

Location

UPMC Health Systems

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasms; Neoplasm Metastasis

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: March 1, 2002
• Primary Completion: May 1, 2003
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

US (6)