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

Sponsors and Collaborators:	Sarah Cannon Research Institute Bristol-Myers Squibb Eli Lilly and Company
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193310

Purpose

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).

Condition	Intervention	Phase
Lung Cancer	Drug: Paclitaxel Drug: Carboplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rates

Secondary Outcome Measures:

Resectability rates
Survival
Time to progression
Toxicity

Estimated Enrollment:	250
Study Start Date:	November 2000
Study Completion Date:	January 2009
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

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.

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193310

Sponsors and Collaborators

Sarah Cannon Research Institute

Bristol-Myers Squibb

Eli Lilly and Company

Investigators

Principal Investigator:

Anthony Greco, MD

Sarah Cannon Research Institute

More Information

No publications provided

Study ID Numbers:	SCRI LUN 53
Study First Received:	September 12, 2005
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00193310 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Adjuvants, Immunologic
Carboplatin
Antimitotic Agents
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms

Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009