EPO906 Therapy in Patients With Advanced Melanoma

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00035165

Collaborator

(none)

Enrollment

Locations

Arm

8.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: epothilone b	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

May 1, 2003

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Tumor response (complete response (CR), partial response (PR), stable disease (SD)) [at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)]
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 [as necessary]
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) [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]
For biomarker development

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Aurora	Colorado	United States	80045
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
3	Comprehensive Cancer Center@ Our Lady if Mercy Medical Center	Bronx	New York	United States	10466-2697
4	Duke University Medical Center	Durham	North Carolina	United States	27710
5	Oklahoma Oncology, Inc.	Tulsa	Oklahoma	United States	74104
6	UPMC Health Systems	Pittsburgh	Pennsylvania	United States	15213