A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

Eli Lilly and Company103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

Interventions

LY573636-sodiumDRUG

LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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.

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)

Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.

Time frame: Baseline to measured progressive disease up to 12.68 months

Secondary Outcomes

Progression Free Survival

Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Time frame: Baseline to measured progressive disease or death due to any cause up to 21.26 months

Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate)

Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100.

Time frame: Baseline to measured progressive disease up to 21.26 months

Pharmacokinetics: Maximum Concentration (Cmax) of LY573636

Time frame: Predose up to 2 hours postdose in Cycles 1 and 2

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Aurora, Colorado, United States

Chicago, Illinois, United States

New York, New York, United States

Oklahoma City, Oklahoma, United States

Brescia, Italy

Rome, Italy

Moscow, Russia

Overall Survival

Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact.

Time frame: First treatment to death due to any cause up to 42.91 months

Duration of Response

The duration of response (complete response \[CR\] or partial response \[PR\]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.

Time frame: Time of response to time of measured progressive disease up to 12.68 months

Duration of Stable Disease

Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Time frame: Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months

Number of Participants With Adverse Events (Safety)

Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.

Time frame: First treatment dose up to 43.91 months