Clinical trial · Interventional
Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial
- 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: 1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2. Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer. 3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the objective tumor response rate for pemetrexed plus gemcitabine every 21 days in patients with malignant pleural mesothelioma who have not received prior chemotherapy
Secondary outcomes (2)
- measure
- To assess time to objective tumor response for responding patients;To assess duration of response for responding patients;To assess time to treatment failure;To assess time to progressive disease
- measure
- To assess progression-free survival;To assess overall survival;To determine toxicities of pemetrexed in combination with gemcitabine in this population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of mesothelioma that can be treated with chemotherapy * Have received no prior chemotherapy for mesothelioma * Have at least one measurable lesion * Have an adequate performance status * Sign an informed consent Exclusion Criteria: * Previous treatment with chemotherapy for mesothelioma * Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed * Treatment with radiation therapy within the last 4 weeks * Brain metastasis that is uncontrolled * Active infection or other serious condition
References
Publications (0)
Data not yet available