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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:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193310
First received: September 12, 2005
Last updated: January 21, 2009
Last verified: January 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
SCRI Development Innovations, LLC
Bristol-Myers Squibb
Eli Lilly and Company
Investigators
Principal Investigator: Anthony Greco, MD SCRI Development Innovations, LLC
  More Information

No publications provided

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014