Clinical trial · Interventional
Chemotherapy for Patients With Osteosarcoma
Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas
- 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 primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition. * To assess how well treatment with pemetrexed works for patients with your type of cancer * To assess for any side effects that might be associated with pemetrexed. * To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- description
- Participants received pemetrexed 500 milligrams per square meter (mg/m\^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle.
- interventionNames
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Percentage of Participants With Tumor Response
- timeFrame
- Baseline to 21 months
- description
- Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis \* 100.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of high grade locally advanced or metastatic osteosarcoma * Must have one prior chemotherapy regimen for advanced disease * At least 1 unidimensional measurable lesion by computed tomography (CT) scan * Have a good performance status * Adequate organ function Exclusion Criteria: * Have a serious concomitant systemic disorder (for example active Human Immunodeficiency Virus infection) * Have brain metastases not adequately treated * Significant weight loss (that is more than 20%) over the previous 6 weeks before study entry * Inability or unwillingness to take folic acid or vitamin B12 supplementation and corticosteroids * Pregnant or breast-feeding
References
Publications (0)
Data not yet available