Study of Pemetrexed in the Treatment of Patients With Ovarian Cancer Who Have Failed Prior Platinum-Based Chemotherapy

Phase 2

Completed

• Conditions: Ovarian Neoplasms; Primary Peritoneal Cancer

• Registration Number: NCT00109096
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purposes of this study are to determine: - whether standard or higher doses of pemetrexed should be given to patients with ovarian or primary peritoneal cancer that has recurred; - the safety and side effects of standard and higher doses of pemetrexed given to patients with ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-04-22
• Study First Submitted QC: 2005-04-22
• Study First Posted: 2005-04-25
• Study Start: 2005-06
• Study Completion: 2007-03
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-16
• Last Update Posted: 2007-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patient must have been diagnosed with ovarian or primary peritoneal cancer
• Patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens.
• Patient must have adequate health status.
• Patient compliance and geographic proximity that allow for adequate follow up is required.
• Signed informed consent from the patient or legal representative is required.

Exclusion Criteria

• Patient is pregnant or breast-feeding
• Patient has received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• Patient has previously participated in another study investigating pemetrexed.
• Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, and corticosteroids.
• Patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of administration of study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess the anti-tumor activity, as measured by tumor response rate (proportion of patients with complete or partial response, of 500 mg/m2 vs. 900 mg/m2 of pemetrexed therapy administered every 21 days

Secondary Outcome Measures

Name	Time	Method
OS
To assess safety and toxicity profile of two doses of pemetrexed in patients with ovarian cancer
Time to response
Duration of response
Time to objective progressive disease (TtPD)
Time to treatment failure (TtTF)
Objective PFS

Trial Locations

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇪🇸 Valencia, Spain

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.; 🇬🇧 Sutton, United Kingdom