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NCT02838745 · ClinicalTrials.gov registry record · Phase 1
Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02838745: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT02838745 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02838745, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Primary Objective To determine the maximum tolerated dose (MTD) of intrathoracic administration of pemetrexed when given in conjunction with cisplatin in patients with resectable malignant pleural mesothelioma MPM. Secondary Objectives To determine the toxicity and grades associated with cytoreductive surgery and Hyperthermic Intraoperative Chemotherapy HIOC with cisplatin and pemetrexed in patients with resectable MPM. To assess overall survival and progression-free survival after PD or EPP and HIOC with cisplatin and pemetrexed for MPM Correlative Objectives To characterize the pharmacokinetics and pharmacodynamics of pemetrexed when administered as a hyperthermic intrathoracic lavage after PD or EPP To determine whether the degree of thymidylate synthase and ERCC1 gene expression in MPM tissue correlates with clinical response to pemetrexed.
Primary Outcome
Dose limiting toxicity (DLT) is defined as: 1) Grade 4 treatment-related hematologic toxicity that lasts more than for 5 days or grade 3 thrombocytopenia with grade 3 or 4 bleeding, 2) Febrile neutropenia, 3) Grade 3 or greater treatment related non-hematologic toxicity with the following exceptions:Grade 3 diarrhea is a dose limiting toxicity DLT only if the patient was compliant with an anti-diarrheal program consistent with best clinical practice; Grade 3 or 4 nausea and vomiting is a dose li
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2016-09 |
| Est. Completion | 2019-09-05 |
| Phase | Phase 1 |
Why NCT02838745 stopped before completion
NCT02838745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.
NCT02838745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02838745 about?
NCT02838745 is a clinical study titled "Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM". Primary Objective To determine the maximum tolerated dose (MTD) of intrathoracic administration of pemetrexed when given in conjunction with cisplatin in patients with resectable malignant pleural mesothelioma MPM. Secondary Objectives To determine the toxicity and grades associated with cytoredu...
What is the current status of trial NCT02838745?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2016-09. Estimated completion is 2019-09-05.
What interventions are being tested in trial NCT02838745?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT02838745?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02838745's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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