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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191126

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 III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

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
B: Experimental	Drug: gemcitabine 1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles 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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009