Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

This study has been completed.

Sponsor:

Collaborators:

Bristol-Myers Squibb

Eli Lilly and Company

Information provided by:

Sarah Cannon Research Institute

ClinicalTrials.gov Identifier:

NCT00193310

First received: September 12, 2005

Last updated: January 21, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 21, 2009

Start Date ^ICMJE

November 2000

Primary Completion Date

November 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall response rates

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00193310 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Resectability rates
Survival
Time to progression
Toxicity

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

Official Title ^ICMJE

Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

Brief Summary

In this phase II study, we plan to evaluate several novel components of therapy. In patients with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week carboplatin in the preoperative (neoadjuvant) setting. For patients with potentially resectable stage IB, IIA and IIB (T2N1) tumors, weekly paclitaxel and every 4 week carboplatin will be given pre-operatively (neoadjuvant). The feasibility of resection will be evaluated in the neoadjuvant group of patients. The continued study of concurrent radiation therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage IIB (T3N0) and IIIA disease who initially had resection (adjuvant setting). Lastly, weekly paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients who had completely resected stage IB, IIA and IIB (T2N1).

Detailed Description

Upon determination of eligibility, neo-adjuvant patients will be randomly assigned to one of two treatment arms:

ARM A Paclitaxel + Carboplatin + Radiation Therapy + Surgery
ARM B Paclitaxel + Carboplatin + Surgery

After surgery neo-adjuvant patients with a complete resection will either receive Paclitaxel + Carboplatin or no therapy, depending on their stage of disease at time of enrollment. Patients with incomplete resection Paclitaxel + Carboplatin + Radiation Therapy. Adjuvant patients who enter the study after complete resection will receive Paclitaxel + Carboplatin with or without Radiation Therapy based on initial stage of disease.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: Paclitaxel
Drug: Carboplatin

Study Arm (s)

Not Provided

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

250

Completion Date

January 2009

Primary Completion Date

November 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Non-small cell lung cancer
Neoadjuvant candidates must have potentially resectable disease
Adjuvant candidates must have had complete resection
Clinical stage IB, II, or IIIA non-small cell lung cancer
ECOG performance status 0 or 1
Adequate bone marrow, liver and kidney function
No previous chemotherapy or radiation therapy for non-small cell lung cancer.
Give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Stage IIIA with N2 nodes > 6 cm
Stage IIIB or IV disease
Age <18 years
ECOG performance status 2 or higher
Considered inoperable based on general medical condition
History of prior malignancy within five years
Women who are pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00193310

Other Study ID Numbers ^ICMJE

SCRI LUN 53

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sarah Cannon Research Institute

Collaborators ^ICMJE

Bristol-Myers Squibb
Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Anthony Greco, MD

Sarah Cannon Research Institute

Information Provided By

Sarah Cannon Research Institute

Verification Date

January 2009

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

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