Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00477282
First received: May 21, 2007
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.


Condition Intervention Phase
Ovarian Cancer
Drug: Karenitecin
Drug: Topotecan
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 Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Incidence of Anemia [ Time Frame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration. ] [ Designated as safety issue: Yes ]
  • Incidence of Neutropenia [ Time Frame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration ] [ Designated as safety issue: Yes ]
  • Incidence of Thrombocytopenia [ Time Frame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration ] [ Designated as safety issue: Yes ]

Enrollment: 509
Study Start Date: August 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Karenitecin Drug: Karenitecin
Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
Other Name: BNP1350
Active Comparator: Topotecan Drug: Topotecan
Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days)
Other Name: Hycamtin

  Eligibility

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed diagnosis of stage III or IV epithelial ovarian cancer
  • Have cancer that is resistant to platinum/taxane-based chemotherapy regimens
  • Have measurable, progressive disease
  • Have an ECOG PS ≤ 2

Exclusion Criteria:

  • Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
  • Have a life expectancy < 3 months
  • Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
  • Received prior treatment with any platinum agent other than cisplatin or carboplatin.
  • Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477282

  Show 48 Study Locations
Sponsors and Collaborators
BioNumerik Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00477282     History of Changes
Other Study ID Numbers: KTN32313R
Study First Received: May 21, 2007
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BioNumerik Pharmaceuticals, Inc.:
Ovarian
Cancer
Advanced Ovarian Cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Camptothecin
Topotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014