A Study of Chemotherapy Treatment for Patients With Ovarian Cancer


Tracking Information

Start Date  ICMJEFebruary 2007
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 21, 2007)		Objective response rate (complete response and partial response) [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: January 26, 2007)		Objective response rate (complete response and partial response)
Change HistoryComplete list of historical versions of study NCT00428610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 21, 2007)
  • Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (complete response + partial response + stable disease) [ Time Frame: baseline to measured proressive disease ] [ Designated as safety issue: No ]
  • Evaluate pharmacokinetics [ Time Frame: Cycle 1 - Cycle 6 ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • duration of response [ Time Frame: time of response to time of measured progressive disease ] [ Designated as safety issue: No ]
  • duration of stable disease [ Time Frame: baseline to time of measured progressive disease ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: January 26, 2007)
  • Progression Free Survival
  • Clinical Benefit Rate (complete response + partial response + stable disease)
  • Evaluate pharmacokinetics
  • Time to event variables: overall survival, duration of response, duration of stable disease

Descriptive Information

Brief Title  ICMJEA Study of Chemotherapy Treatment for Patients With Ovarian Cancer
Official Title  ICMJEA Phase 2 Study of LY573636 as Treatment for Patients With Platinum-Resistant Ovarian Cancer
Brief Summary

The primary objective is to determine whether LY573636 is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. CT scans and CA-125 tests will be done before the first dose and then after every other treatment.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
Intervention  ICMJEDrug: LY573636
LY573636 dose is dependent on patient's height, weight, and gender and is adjusted to target a specific Cmax based on patient laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for patient discontinuation are met.
Study Arms / Comparison GroupsLY573636: Experimental
Intervention: Drug: LY573636

Recruitment Information

Estimated Enrollment  ICMJE100
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  • At least 18 years old
  • Have received at least one but no more than 2 systemic treatment regimens containing platinum (does not include regimens received before surgery for this cancer)
  • Have platinum-resistant disease

Exclusion Criteria:

  • Have received more than 2 systemic treatment regimens for platinum-resistant disease
  • Serious pre-existing medical conditions
  • Actively receiving warfarin (Coumadin) for treatment of venous thrombosis or other prothrombotic conditions
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)1-317-615-4559
Location Countries  ICMJEUnited States,   Italy,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00428610
Responsible PartyChief Medical Officer, Eli Lilly and Company
Study ID Numbers  ICMJE10410, H8K-MC-JZAG
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Eli Lilly and Company
Information Provided ByEli Lilly and Company