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

Phase 2

Completed

• Conditions: Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms
• Interventions: Drug: epothilone b

• Registration Number: NCT00035100
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Primary Completion: 2003-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPO906	epothilone b	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Surrey, United Kingdom