Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00262990

First received: December 6, 2005

Last updated: May 2, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 6, 2005

Last Updated Date

May 2, 2012

Start Date ^ICMJE

November 2005

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00262990 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD) [ Time Frame: End of study ] [ Designated as safety issue: No ]
To determine the progression-free survival (PFS) of patients treated with patupilone [ Time Frame: end of study ] [ Designated as safety issue: No ]
To determine the time to disease progression (TTP) of patients treated with patupilone [ Time Frame: end of study ] [ Designated as safety issue: No ]
To determine overall best tumor response (CR, PR, SD, PD and Unknown) [ Time Frame: end of study ] [ Designated as safety issue: No ]
To investigate the safety and tolerability of patupilone [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
To evaluate the pharmacokinetics (PK) of patupilone from all patients [ Time Frame: end of study ] [ Designated as safety issue: No ]
To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events [ Time Frame: end of study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

Official Title ^ICMJE

A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer

Brief Summary

The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms

Intervention ^ICMJE

Drug: EPO906 (Patupilone)
Other Name: Patupilone
Drug: doxorubicin

Study Arm (s)

Experimental: Patupilone
Intervention: Drug: EPO906 (Patupilone)
Active Comparator: doxorubicin
Intervention: Drug: doxorubicin

Publications *

Colombo N, Kutarska E, Dimopoulos M, Bae DS, Rzepka-Gorska I, Bidzinski M, Scambia G, Engelholm SA, Joly F, Weber D, El-Hashimy M, Li J, Souami F, Wing P, Engelholm S, Bamias A, Schwartz P. Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. J Clin Oncol. 2012 Nov 1;30(31):3841-7. doi: 10.1200/JCO.2011.38.8082. Epub 2012 Sep 17.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

829

Completion Date

Not Provided

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age or older
Confirmed diagnosis of ovarian, fallopian or peritoneal cancer
No more than three chemotherapy regimens
Most recent regimen must have been platinum based

Exclusion Criteria:

Have an unresolved bowel obstruction
Have had previous chemotherapy within 3 weeks
Recovering from any surgery for any cause

Other protocol-defined inclusion/exclusion criteria will apply.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Denmark, Finland, France, Greece, Italy, Poland, South Africa, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00262990

Other Study ID Numbers ^ICMJE

CEPO906A2303

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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