Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00262990

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms	Drug: EPO906 (Patupilone) Drug: Doxil	Phase III

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Epothilone B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

To evaluate progression free survival (PFS)
to evaluate best overall response rate (CR, PR) per RECIST criteria

Estimated Enrollment:	810
Study Start Date:	November 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: EPO906 (Patupilone)
2: Active Comparator	Drug: Doxil

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262990

Contacts

Contact: Novartis

1-800-340-6843

Show 152 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Related Info This link exits the ClinicalTrials.gov site

In the search box enter NCT00262990 This link exits the ClinicalTrials.gov site

Select "Ovarian Cancer" This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CEPO906A2303
Study First Received:	December 6, 2005
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00262990
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Epithelial ovarian cancer
fallopian tube cancer
peritoneal cancer
primary cancer
recurrent cancer

doxorubicin
taxane chemotherapy
platinum chemotherapy
Patupilone
taxane platinum resistant

Study placed in the following topic categories:

Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Genital Diseases, Female
Peritoneal Diseases
Taxane
Endocrine Gland Neoplasms
Ovarian cancer
Epothilone B
Ovarian Neoplasms
Digestive System Neoplasms
Epothilones

Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Recurrence
Fallopian Tube Neoplasms
Doxorubicin
Fallopian Tube Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Fallopian tube cancer
Endocrinopathy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009