CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
pemetrexed disodium +2 moredrug
Likely dose
Pemetrexed 500 mg/m2 IV on day 1 combined with gemcitabine 1000 mg/m2 IV on days 1 and 8, or carboplatin AUC 5 IV on day 1, all in 21-day cyclesAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed advanced mesothelioma of the pleura
  • ✓Measurable disease by RECIST criteria or evaluable by mesothelioma response criteria within 4 weeks of randomization
  • ✓ECOG Performance Status 0 or 1
  • ✓Age 18 years or older
Key exclusion· 10
  • ✕Candidate for curative surgery
  • ✕Prior systemic chemotherapy for mesothelioma (prior intracavitary cytotoxic drugs/immunomodulators allowed only for pleurodesis)
  • ✕Prior radiation to target lesion unless clearly progressing per RECIST with ≥4 weeks since last radiation
  • ✕Active infection or serious concomitant systemic disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00101283
NCT00101283Phase 2Completed
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Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial

Eastern Cooperative Oncology Group·interventional·Posted Jan 10, 2005·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating pemetrexed disodium, gemcitabine hydrochloride, and 1 other intervention for Mesothelioma. Completed, enrolled 32 participants across 115 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma. PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMesothelioma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), North Central Cancer Treatment Group

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2005
Enrollment StartFeb 23, 2006
Primary CompletionSep 1, 2009
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.5 years ago

Interventions

pemetrexed disodiumdrug

500 mg/m2 IV over 10 minutes on day 1 of a 21-day cycle

gemcitabine hydrochloridedrug

1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle

carboplatindrug

Given by IV over 30 minutes at an area under the curve (AUC) of 5 on day 1 of a 21-day cycle