Clinical trial NCT00035100: EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Keywords: ovarian
ovary
peritoneal cancer
fallopian cancer
cancer
tumor
tumour
neoplasm
carcinoma
intravenous
epothilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
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 ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.


Eligibility criteria: 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.

Primary outcomes:
measure: Tumor response rate
timeFrame: Every 2 cycles
Secondary outcomes:
measure: Time to disease progression
timeFrame: from start of treatment to documented disease progression, death from study indication, or the date of last follow-up
measure: Overall survival
timeFrame: measured from the start of treatment to the date of death or the last date the patient was known to be alive.
measure: Duration of response
timeFrame: Every 3 months
measure: recording all adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Every 3 months
measure: pharmacogenetic analyses with blood and tumor samples from these patients
timeFrame: Every 3 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Zwolle
country: Netherlands
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Surrey
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: