Clinical trial NCT00428610: A Study of Chemotherapy Treatment for Patients With Ovarian Cancer
Official title: A Phase 2 Study of LY573636-Sodium as Treatment for Patients With Platinum-Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-01-30
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)
timeFrame: Baseline to measured progressive disease up to 12.68 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Baseline to measured progressive disease or death due to any cause up to 21.26 months
measure: Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate)
timeFrame: Baseline to measured progressive disease up to 21.26 months
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
timeFrame: Predose up to 2 hours postdose in Cycles 1 and 2
measure: Overall Survival
timeFrame: First treatment to death due to any cause up to 42.91 months
measure: Duration of Response
timeFrame: Time of response to time of measured progressive disease up to 12.68 months
measure: Duration of Stable Disease
timeFrame: Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months
measure: Number of Participants With Adverse Events (Safety)
timeFrame: First treatment dose up to 43.91 months
Other outcomes:
measure: Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
timeFrame: Study treatment discontinuation up to 30 days post study treatment discontinuation
Locations:
city: Scottsdale
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Aurora
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Colorado
city: Chicago
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
city: New York
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New York
city: Oklahoma City
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Oklahoma
city: Brescia
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Rome
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: