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Completed

NCT Number: NCT00262990

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

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.

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Key information

Conditions

Ovarian Cancer Abdominal Neoplasms Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritoneal Neoplasms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EPO906 (patupilone)

Drug

Other names: Patupilone

Doxorubicin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2010
First posted
Dec 7, 2005
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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