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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 20, 2008

Start Date ^ICMJE

September 2000

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To assess whether preoperative chemotherapy with gemcitabine and cisplatin for 3 cycles improves progression-free survival compared to surgery alone in previously untreated patients with clinical Stage IB, II and Selected III A non-small cell lung cancer

Change History

Complete list of historical versions of study NCT00191126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To compare the survival and sites of relapse in the two study arms.
To compare operative mortality and other toxicities in the two study arms.
To evaluate the response rates (confirmed and unconfirmed) and the toxicities associated with the combination of
gemcitabine and cisplatin.
To obtain samples for correlation of radiologic, pathologic, molecular and biologic factors with outcome.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-Small Cell Lung Cancer

Intervention ^ICMJE

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

Study Arm (s)

A
Intervention: Procedure: surgery
Experimental: B
Interventions:
- Drug: gemcitabine
- Drug: Cisplatin
- Procedure: surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

263

Completion Date

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, Bosnia and Herzegovina, Bulgaria, Egypt, Estonia, Germany, Hungary, Italy, Lithuania, Poland, Romania, Saudi Arabia, Slovakia, Sweden, Taiwan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00191126

Other Study ID Numbers ^ICMJE

3532, B9E-MC-S132

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Chief Medical Officer, Eli Lilly

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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