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Alimta and Gemcitabine in Non-Small Cell Lung Cancer

NCT00434135 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2009-02-05

No results posted yet for this study

Summary

The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL

Conditions

Interventions

DRUG

gemcitabine plus pemetrexed, paclitaxel plus gemcitabine

gemcitabine 1,250 mg/sqm days 1\&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1\&8

Sponsors & Collaborators

  • Southern Italy Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Pasquale Comella, MD · National Tumor Institute, Naples, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-10-31
Completion
2008-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00434135 on ClinicalTrials.gov