EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00035100

Collaborator

(none)

Enrollment

Locations

Arm

6.8

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 ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms	Drug: epothilone b	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Non-Randomized

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 Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EPO906	Drug: epothilone b Other Names: EPO906

Arm

Intervention/Treatment

Experimental: EPO906

Drug: epothilone b

Other Names:

EPO906

Outcome Measures

Primary Outcome Measures

Tumor response rate [Every 2 cycles]
tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

Secondary Outcome Measures

Time to disease progression [from start of treatment to documented disease progression, death from study indication, or the date of last follow-up]
Overall survival [measured from the start of treatment to the date of death or the last date the patient was known to be alive.]
Duration of response [Every 3 months]
duration of response in patients with complete response (CR) or partial response (PR)
recording all adverse events (AEs) and serious adverse events (SAEs) [Every 3 months]
Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations
pharmacogenetic analyses with blood and tumor samples from these patients [Every 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

The following patients may be eligible for the study:

Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
Must have a life expectancy of greater than three (3) months
Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.

Exclusion Criteria:

The following patients are not eligible for the study:

Patients with radiation therapy or chemotherapy within the last four weeks
Patients who have had any chemotherapy not containing a taxane and platinum for their disease
Patients with borderline ovarian and macropapillary tumors
Patients with unresolved bowel obstruction
Patients with symptomatic CNS metastases or leptomeningeal involvement
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
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	Novartis Investigative Site	New Brunswick	New Jersey	United States	08901
2	Novartis Investigative Site	Toronto	Ontario	Canada	M5G 2M9
3	Novartis Investigative Site	Amsterdam		Netherlands	1066 CX
4	Novartis Investigative Site	Enschede		Netherlands	7513 ER
5	Novartis Investigative Site	Zwolle		Netherlands	8025 AB
6	Novartis Investigative Site	Bratislava		Slovakia	812 50
7	Novartis Investigative Site	Kosice		Slovakia	04190
8	Novartis Investigative Site	Surrey		United Kingdom	SM2 5PT