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Study in Patients With Advanced Non-Small Cell Lung Cancer Treated With Pemetrexed and Carboplatin Plus or Minus Sorafenib

NCT00473486 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-01-27

No results posted yet for this study

Summary

The majority of patients with advanced NSCLC treated with standard platinum based chemotherapy regimens ultimately develop disease progression. Active therapies with improved toxicity profiles are clearly needed in this setting. The primary objective of this trial is to assess the toxicity profile and to determine the effect on progression free survival and time to progression in patients with advanced NSCLC treated with sorafenib in addition to carboplatin and pemetrexed.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

pemetrexed, carboplatin, sorafenib

Ph. 1: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; Sorafenib 200mg po bid days 2-19; 400mg po bid days 2-19 Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1;sorafenib depending on results of Ph 1

DRUG

pemetrexed, carboplatin, placebo

Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; placebo day 2-19

Sponsors & Collaborators

Principal Investigators

  • Christian Brandts, MD · Universitätsklinikum Münster, Med. Klinik und Poliklinik A, Hämatologie, Onkologie und Pneumologie and Uniklinik Frankfurt Innere Medizin, Hämatologie/Onkologie, 60590 Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-08-31
Completion
2010-01-31

Countries

  • Germany

Study Locations

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Entities

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 NCT00473486 on ClinicalTrials.gov