Clinical trial · Interventional
Cisplatin With Alimta or Gemcitabine in Long Infusion for Mesothelioma
Cisplatin With Either Alimta or Gemcitabine in Long Infusion for Mesothelioma: A Randomised Phase II Trial (AGILI Trial)
NCT01281800CI-TRIAL-00004331AGILIunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.
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 |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine in long infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin with pemetrexed
- interventionNames
- Procedure: Gemcitabine in long infusion
- type
- EXPERIMENTAL
- label
- Cisplatin with gemcitabine in long infusion
- interventionNames
- Procedure: Gemcitabine in long infusion
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- CT measurement of disease will be performed after 2nd cycle of chemotherapy, at the end of the treatment and during follow up period up to progression (total average 8 months)
- description
- Efficacy of the treatment will be measured by response rate (RR) and progression free survival (PFS) using modified RECIST criteria for assessment of response in malignant pleural mesothelioma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven mesothelioma. While local histopathology exam is sufficient to register a patient for the trial, all biopsies will be subject to central review (please see Section 5.3.) * no history of other malignancy; or in complete remission for \> 3 years if previously treated for other malignancy; * chemo-naive; * performance status ≥ 70% (Karnofsky); or ECOG 0 - 2 ; * no peripheral neuropathy grade 2 or more (common toxicity criteria - CTC, NCI), unless mechanical in origin; * no vascular disease grade 2 or more (NCI CTC ver.3); * hemoglobin \> 100 g/L; * neutrophils \> 2.0 g/L; * platelets \> 100 x 109 /L; * kidney function: creatinine within normal limits + ECC \> 60 mL/min; or ECC \> 100 mL/min; * liver function: bilirubin \< 1.25 x UNL; AST/ALT \< 2 x UNL; * cardiac compensation; * no active infection or other serious concomitant disease; * women are not pregnant * patient's understanding of the disease and treatment and written informed consent. Exclusion Criteria: • significant medical co-morbidity
References
Publications (0)
Data not yet available
No reference posted for this study.