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

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ClinicalTrials.gov Identifier: NCT00262990
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms Drug: EPO906 (Patupilone) Drug: doxorubicin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 829 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2005
Actual Primary Completion Date : February 2010


Arm Intervention/treatment
Experimental: Patupilone Drug: EPO906 (Patupilone)
Other Name: Patupilone

Active Comparator: doxorubicin Drug: doxorubicin



Primary Outcome Measures :
  1. To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer [ Time Frame: every 8 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. To determine the progression-free survival (PFS) of patients treated with patupilone [ Time Frame: end of study ]
  3. To determine the time to disease progression (TTP) of patients treated with patupilone [ Time Frame: end of study ]
  4. To determine overall best tumor response (CR, PR, SD, PD and Unknown) [ Time Frame: end of study ]
  5. To investigate the safety and tolerability of patupilone [ Time Frame: end of study ]
  6. To evaluate the pharmacokinetics (PK) of patupilone from all patients [ Time Frame: end of study ]
  7. To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events [ Time Frame: end of study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262990


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00262990     History of Changes
Other Study ID Numbers: CEPO906A2303
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Doxorubicin
Liposomal doxorubicin
Taxane
Epothilone B
Epothilones
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators