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

Novartis

Status and phase

Completed

Phase 2

Conditions

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Treatments

Drug: epothilone b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00035100

CEPO906A2203

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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.