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Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00153803
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 13, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Non-small Cell Lung Cancer NSCLC Drug: Erlotinib (tarceva) Drug: Placebo Phase 3

Detailed Description:
The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-three survival time for these patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).
Study Start Date : May 2005
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Tarceva 150mg
Drug: Erlotinib (tarceva)
Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 5 years of therapy.
Placebo Comparator: 2
Matched Placebo
Drug: Placebo
Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 5 years of therapy.


Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: survival ]
  2. 2 year survival [ Time Frame: 24 months ]
  3. Assess the serious adverse event profile for erlotinib [ Time Frame: 18 months ]
  4. Assess molecular targets as potential markers of efficacy [ Time Frame: optional 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
  • No evidence of metastatic disease
  • No prior treatment
  • Adequate organ function
  • Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)

Exclusion Criteria:

  • Metastasis
  • Prior treatment
  • Malignant pleural or pericardial effusion
  • Peripheral neuropathy >= grade 2
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153803


  Show 65 Study Locations
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Sanofi
Genentech, Inc.
Investigators
Study Chair: James R Rigas, MD Norris Cotton Cancer Center
More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00153803     History of Changes
Other Study ID Numbers: D-0410
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

Keywords provided by Dartmouth-Hitchcock Medical Center:
Erlotinib
Tarceva
Web based
Stage III NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action