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

Phase 3

Completed

• Conditions: Peritoneal Neoplasms; Ovarian Cancer; Fallopian Tube Cancer
• Interventions: Drug: EPO906 (Patupilone); Drug: doxorubicin

• Registration Number: NCT00262990
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Primary Completion: 2010-02
• Status Verified: 2012-05
• Disposition First Submitted: 2012-05-01
• Disposition First Submitted QC: 2012-05-01
• Disposition First Posted: 2012-05-03
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 829

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patupilone	EPO906 (Patupilone)	-
doxorubicin	doxorubicin	-

Primary Outcome Measures

Name	Time	Method
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer	every 8 weeks

Secondary Outcome Measures

Name	Time	Method
To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)	End of study
To determine the progression-free survival (PFS) of patients treated with patupilone	end of study
To determine the time to disease progression (TTP) of patients treated with patupilone	end of study
To determine overall best tumor response (CR, PR, SD, PD and Unknown)	end of study
To investigate the safety and tolerability of patupilone	end of study
To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events	end of study
To evaluate the pharmacokinetics (PK) of patupilone from all patients	end of study

Trial Locations

Locations (96)

Alaska Cancer Research & Education Center; 🇺🇸 Anchorage, Alaska, United States

Northern Arizona Hematology & Oncology Associates; 🇺🇸 Sedona, Arizona, United States

Mayo Center for Women's Health; 🇺🇸 Scottsdale, Arizona, United States

Genesis Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Yanagihara, Ronald H.; 🇺🇸 Gilroy, California, United States

California Cancer Care, Inc.; 🇺🇸 Greenbrae, California, United States

University of California - San Diego/ Moores Cancer Center; 🇺🇸 La Jolla, California, United States

LAC & USC Women's & Children's Hospital; 🇺🇸 Los Angeles, California, United States

Gynecologic Oncology associates; 🇺🇸 Newport Beach, California, United States

Scroll for more (86 remaining)