Clinical trial · Interventional
Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery
Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin and vitamin B12 may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery.
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 |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| vitamin B12 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Individual dosage-adapted protocol
Secondary outcomes (3)
- measure
- Relationship between pharmacokinetic and pharmacodynamic parameters
- measure
- Pharmacokinetics
- measure
- Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed pleural mesothelioma * Unresectable disease Exclusion criteria: * Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures PATIENT CHARACTERISTICS: Inclusion criteria: * WHO performance status 0-2 * Life expectancy \> 3 months * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine clearance \> 45 mL/min * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Transaminases ≤ 3 times ULN (5 times ULN if liver metastases) * Not pregnant or nursing * Fertile patients of must use effective contraception during and for 6 months after completion of study treatment Exclusion criteria: * Hypersensitivity to pemetrexed disodium or any of its excipients * Peripheral neuropathy ≥ grade 2 * Impossible to receive study therapy due to geographical, social, familial, or psychological reasons PRIOR CONCURRENT THERAPY: Inclusion criteria: * At least 28 days since prior radiotherapy (21 days for injected radiotherapy) Exclusion criteria: * Prior chemotherapy * Prior yellow fever vaccine * Inability to discontinue aspirin (\> 1.3 g/day) or NSAIDs for 2 days prior to, during, and 2 days after day 1 of each course of study therapy * Concurrent participation in another clinical study
References
Publications (0)
Data not yet available