Clinical trial · Interventional
Study of Pemetrexed in the Treatment of Patients With Ovarian Cancer Who Have Failed Prior Platinum-Based Chemotherapy
A Randomized, Double-Blind Phase 2 Study of Two Doses of Pemetrexed in the Treatment of Platinum-Resistant, Epithelial Ovarian or Primary Peritoneal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 (7)
- measure
- Time to response
- measure
- Duration of response
- measure
- Time to objective progressive disease (TtPD)
- measure
- Time to treatment failure (TtTF)
- measure
- Objective PFS
- measure
- OS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available