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

Eli Lilly and Company Limited0 个研究点目标入组 100 人开始时间: 2005年3月22日最近更新: 2013年4月29日

试验速览

暂无简介。

•- 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

•- 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.

发起方