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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
  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: doxorubicin
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 829
Study Start Date: November 2005
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patupilone Drug: EPO906 (Patupilone)
Other Name: Patupilone
Active Comparator: doxorubicin Drug: doxorubicin

  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

  Show 149 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
In the search box enter NCT00262990  This link exits the ClinicalTrials.gov site
Select "Ovarian Cancer"  This link exits the ClinicalTrials.gov site

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00262990     History of Changes
Other Study ID Numbers: CEPO906A2303
Study First Received: December 6, 2005
Last Updated: May 2, 2012
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

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
 Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Doxorubicin
Epothilone B
Epothilones
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013