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

Eli Lilly and Company100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Ovarian Neoplasms Primary Peritoneal Cancer

Interventions

PemetrexedDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Outcomes

Primary Outcomes

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 Outcomes

Time to response

Duration of response

Time to objective progressive disease (TtPD)

Time to treatment failure (TtTF)

Objective PFS

To assess safety and toxicity profile of two doses of pemetrexed in patients with ovarian cancer

Data from ClinicalTrials.gov

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

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.

Brussels, Belgium

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.

Leuven, Belgium

Berlin, Germany

Erlangen, Germany

Hamburg, Germany

Homburg/Saar, Germany

Jena, Germany

Magdeburg, Germany

Mainz, Germany

München, Germany

...and 11 more locations