EPO906 Therapy in Patients With Advanced Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00035165
First received: May 2, 2002
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: epothilone b
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Tumor response (complete response (CR), partial response (PR), stable disease (SD)) [ Time Frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle) ] [ Designated as safety issue: No ]
    Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.


Secondary Outcome Measures:
  • Number and percentage of patients with Adverse events [ Time Frame: as necessary ] [ Designated as safety issue: Yes ]
    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.

  • Objective response rate (ORR) [ Time Frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle) ] [ Designated as safety issue: No ]
  • Time to disease progression (TTP) [ Time Frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle) ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma [ Time Frame: 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 ] [ Designated as safety issue: No ]
    For biomarker development


Enrollment: 51
Study Start Date: March 2002
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Patupilone, EPO906

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035165

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00035165     History of Changes
Other Study ID Numbers: CEPO906A2206
Study First Received: May 2, 2002
Last Updated: April 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
melanoma
cancer
tumor
tumour
malignant
metastatic
intravenous
epothilone

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Epothilone B
Epothilones
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014