Ovarian Neoplasms, Primary Peritoneal Cancer
Conditions
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.
Interventions
DRUGPemetrexed
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Duration of response | — |
| Time to objective progressive disease (TtPD) | — |
| Time to treatment failure (TtTF) | — |
| Time to response | — |
| OS | — |
| To assess safety and toxicity profile of two doses of pemetrexed in patients with ovarian cancer | — |
| Objective PFS | — |
Countries
Belgium, Germany, Spain, United Kingdom
Outcome results
None listed