EPO906 Therapy in Patients With Advanced Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035165
• Other study ID #: CEPO906A2206
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: April 24, 2012
• Start date: March 2002

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Comprehensive Cancer Center@ Our Lady if Mercy Medical Center	Bronx	New York
United States	Duke University Medical Center	Durham	North Carolina
United States	UPMC Health Systems	Pittsburgh	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Oklahoma Oncology, Inc.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	Yes
Secondary	Objective response rate (ORR)		at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No