CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
pemetrexed +1 moredrug
Likely dose
Pemetrexed 500 mg/m² IV every 21 days × 4 cycles; Cisplatin 75 mg/m² IV every 21 days × 4 cyclesAI-extracted
Key inclusion· 7
  • ✓Clinically or radiologically staged M0 disease (no distant metastases)
  • ✓T1, T2, or T3 disease without cardiac involvement
  • ✓N0, N1, or N2 nodal status
  • ✓ECOG performance status 0 or 1
Key exclusion· 4
  • ✕Prior pemetrexed treatment or withdrawal from pemetrexed studies
  • ✕Pregnancy or breast-feeding
  • ✕Serious concomitant systemic disorders (e.g., active infection) that compromise patient safety or study completion
  • ✕Second active primary malignancy (with limited exceptions for in situ cervical carcinoma, skin cancer, low-grade prostate cancer, or malignancy treated ≥2 years prior with no recurrence)

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

Search/NCT00087698
NCT00087698Phase 2Completed
CompareCT.gov

A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

Eli Lilly and Company·interventional·Posted Jul 16, 2004·Updated May 12, 2009

In Brief

A Phase 2 clinical trial evaluating pemetrexed and cisplatin for Pleural Neoplasms. Completed, enrolled 77 participants across 7 sites.

Detailed Summary

This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPleural Neoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2004
Enrollment StartSep 1, 2003
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 22.0 years ago

Interventions

pemetrexeddrug

500 mg/m2, intravenous (IV), every 21 days x 4 cycles

cisplatindrug

75 mg/m2, intravenous (IV), every 21 days x 4 cycles