CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
gemcitabine HCL +2 moredrug
Likely dose
gemcitabine HCL 1250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00407550
NCT00407550Phase 2Completed

A Randomized Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer

Mayo Clinic·interventional·Posted Dec 5, 2006·Updated May 2, 2019

In Brief

A Phase 2 clinical trial evaluating gemcitabine HCL and pemetrexed disodium for Lung Cancer. Completed, enrolled 19 participants across 1 site.

Detailed Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2006
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2008
Study CompletionMay 12, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.6 years ago

Interventions

gemcitabine HCLdrug

1250 mg/m\^2 administered through 250 cc NS (normal saline) IV (intravenous) infusion over 30 minutes at days 1 \& 8 of each cycle (21 days) x6 cycles.

pemetrexed disodiumdrug

500 mg/m\^2 administered through 100 mL NS IV infusion over 10 minutes at day 1 of each cycle.

gemcitabine HCLdrug

1500 mg/m\^2 administered through 250 cc NS IV infusion over 30 minutes at days 1 of each cycle (14 days) x9 cycles.