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

NCT00035100CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Novartis Pharmaceuticals

Enrollment

54

Start Date

2001-09-01

Completion Date

2003-06-01

Study Type

INTERVENTIONAL

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

Interventions

epothilone b

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Tumor response rate

tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

Time frame: Every 2 cycles

Secondary Outcomes

Time to disease progression

Time frame: from start of treatment to documented disease progression, death from study indication, or the date of last follow-up

Overall survival

Time frame: 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

duration of response in patients with complete response (CR) or partial response (PR)

Time frame: Every 3 months

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

Time frame: Every 3 months

pharmacogenetic analyses with blood and tumor samples from these patients

Time frame: Every 3 months

Locations

Novartis Investigative Site, New Brunswick, United States

Novartis Investigative Site, Toronto, Canada

Novartis Investigative Site, Enschede, Netherlands

Novartis Investigative Site, Amsterdam, Netherlands

Novartis Investigative Site, Zwolle, Netherlands

Novartis Investigative Site, Bratislava, Slovakia

Novartis Investigative Site, Košice, Slovakia

Novartis Investigative Site, Surrey, United Kingdom