E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033128 |
E.1.2 | Term | Ovarian cancer |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
to assess the following time-to-event efficacy variables: · time to response · duration of response · time to objective progressive disease (TtPD) · time to treatment failure (TtTF) · objective progression free survival (PFS) · Overall survival to assess the safety and toxicity profile of two doses of pemetrexed
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Tumor response is the primary endpoint of the study. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study will be closed when at least 70% of enrolled patients have experienced disease progression or have died, or 8 months after the last patient is enrolled, whichever occurs later. Since patients with platinum resistant ovarian cancer have a poor prognosis and, unfortunately, progress very fast, it is reasonable to follow-up patients also for time to event variables like PFS, since differences in these varialbles indicate additional benefit for the patients from treatment. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |