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

Ovarian Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035100
• Other study ID #: CEPO906A2203
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: April 13, 2012
• Start date: September 2001

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

Drug:
• epothilone b

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Toronto	Ontario
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative Site	Zwolle
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Kosice
United Kingdom	Novartis Investigative Site	Surrey
United States	Novartis Investigative Site	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response rate	tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).	Every 2 cycles	No
Secondary	Time to disease progression		from start of treatment to documented disease progression, death from study indication, or the date of last follow-up	No
Secondary	Overall survival		measured from the start of treatment to the date of death or the last date the patient was known to be alive.	No
Secondary	Duration of response	duration of response in patients with complete response (CR) or partial response (PR)	Every 3 months	No
Secondary	recording all adverse events (AEs) and serious adverse events (SAEs)	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	Every 3 months	Yes
Secondary	pharmacogenetic analyses with blood and tumor samples from these patients		Every 3 months	Yes