Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191126
First received: September 12, 2005
Last updated: June 20, 2008
Last verified: June 2008
  Purpose

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: gemcitabine
Drug: Cisplatin
Procedure: surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: baseline to measure progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the survival and sites of relapse in the two study arms. [ Time Frame: baseline to progressive disease ] [ Designated as safety issue: No ]
  • Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Pathologic response rate of tissue samples [ Time Frame: baseline, post chemotherapy, post surgery ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: September 2000
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Procedure: surgery
surgery
Experimental: B Drug: gemcitabine
1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles
Other Names:
  • LY188011
  • Gemzar
Drug: Cisplatin
75 mg/m2, IV, q 21 days x 3 cycles
Procedure: surgery
surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main inclusion Criteria:

  • Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
  • ECOG Performance Status of 0 - 1
  • Bidimensionally measurable disease or evaluable disease
  • Adequate organ function

Main exclusion Criteria:

  • Have greater than Grade 1 neuropathy - motor/sensory
  • Significant history of cardiac disease
  • Pleural effusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191126

  Show 37 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191126     History of Changes
Other Study ID Numbers: 3532, B9E-MC-S132
Study First Received: September 12, 2005
Last Updated: June 20, 2008
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014