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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

September 12, 2005
January 21, 2009
November 2000
November 2003   (final data collection date for primary outcome measure)
Overall response rates
Same as current
Complete list of historical versions of study NCT00193310 on ClinicalTrials.gov Archive Site
  • Resectability rates
  • Survival
  • Time to progression
  • Toxicity
Same as current
Not Provided
Not Provided
 
Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer
Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: Paclitaxel
  • Drug: Carboplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
January 2009
November 2003   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193310
SCRI LUN 53
Not Provided
Not Provided
SCRI Development Innovations, LLC
  • Bristol-Myers Squibb
  • Eli Lilly and Company
Principal Investigator: Anthony Greco, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
January 2009

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