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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company
• Treatments: Carboplatin; Paclitaxel

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.