Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem

NCT00612677 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-03-23

Study results available
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Summary

The purpose of this study is:

* To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin (Eloxatin) given together will kill the cancer cells in the patient's body and shrink the size of their tumor. This may allow patients to live longer or decrease the frequency and/or severity of the symptoms caused by the cancer. Pemetrexed has been approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has been approved by the FDA for the treatment of Colon Cancer. The combination of these two drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not yet in the USA

Other purposes of this study are:

* To better detail the toxic effects of this chemotherapy combination.
* To determine whether the level of specific gene and/or gene products (genes are genetic material that allows cells to make proteins such as enzymes) are useful to predict if this chemotherapy combination will work or not.

Conditions

Interventions

DRUG

Oxaliplatin

Dose Regimen: 120 mg/m\^2 on Days 1 every 21 days

DRUG

Pemetrexed

Dose Regimen: 500 mg/m\^2 on Days 1 every 21 days

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY
  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Alberto Chiappori, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00612677 on ClinicalTrials.gov