A Randomized, Double-Blind, Phase 2 Study of Two Doses of Pemetrexed in the Treatment of Platinum-Resistant, Epithelial Ovarian or Primary Peritoneal Cancer

• Conditions: Femals with diagnosis of recurrent, epithelial ovarian or primary peritoneal cancer that is not amenable to curative therapy. Histologic confirmation of the original primary tumor is required. Patients must have platinum resistant disease after first line or second line, platinum containing chemotherapy treatment.; MedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer

• Registration Number: EUCTR2004-002784-24-DE
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-22
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

- diagnosis of recurrent, epithelial ovarian or primary peritoneal cancer that is not amenable to curative therapy. Histologic confirmation of the original primary tumor is required.
- Patients must have platinum-resistant disease: disease recurring less than 6 months after first-line or second-line platinum-based therapy or disease progressing during first-line or second-line platinum-based therapy.
- Patients must have had one or two prior platinum-based chemotherapeutic regimens.
- Patients must have: measurable disease according to RECIST guidelines, or
nonmeasurable disease but CA-125 =2X upper limit of normal at least 2 weeks prior
to study enrollment.
- Patients must have ECOG performance status of 0, 1, or 2.
- estimated life expectancy of >=24 weeks.
- adequate organ function (bone marrow reserve, hepatic and renal function)
- Signed informed
- Female and at least 18 years of age.
- Patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device, birth control pills, or barrier device) during the study. Patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days of study enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- more than 2 lines of therapy.
- have 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.
- pregnant or breast-feeding.
- serious concomitant systemic disorders that, would compromise the safety of the patient and her ability to complete the study.
- inability to interrupt the use of aspirin and/or NSAIDs for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents).
- inability or unwillingness to take folic acid, vitamin B12 supplementation, and corticosteroids.
- have a clinically significant third-space fluid (for example, pleural effusion or ascites) that cannot be managed with drainage.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the antitumor activity, as measured by tumor response rate, of 500 mg/m² versus 900 mg/m² of pemetrexed therapy administered every 21 days.;Secondary Objective: to assess the following time-to-event efficacy variables:<br>·time to response<br>·duration of response<br>·time to objective progressive disease (TtPD)<br>·time to treatment failure (TtTF)<br>·objective progression free survival (PFS)<br>·Overall survival<br>to assess the safety and toxicity profile of two doses of pemetrexed<br>;Primary end point(s): Tumor response is the primary endpoint of the study.