Clinical trial NCT00035165: EPO906 Therapy in Patients With Advanced Melanoma
Official title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: melanoma
cancer
tumor
tumour
malignant
metastatic
intravenous
epothilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Tumor response (complete response (CR), partial response (PR), stable disease (SD))
timeFrame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Secondary outcomes:
measure: Number and percentage of patients with Adverse events
timeFrame: as necessary
measure: Objective response rate (ORR)
timeFrame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
measure: Time to disease progression (TTP)
timeFrame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
measure: Overall Survival (OS)
timeFrame: 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
measure: Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
timeFrame: 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
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Bronx
country: United States
facility: Comprehensive Cancer Center@ Our Lady if Mercy Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Oncology, Inc.
state: Oklahoma
city: Pittsburgh
country: United States
facility: UPMC Health Systems
state: Pennsylvania
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: