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

NCT00193310 | Completed Phase 2

• 1 other identifier: SCRI LUN 53
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rates

Secondary Outcomes (4)

• Resectability rates

• Survival

• Time to progression

• Toxicity

Interventions

Paclitaxel DRUG

Carboplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Bristol-Myers Squibb: collaborator
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Anthony Greco, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: November 1, 2000
• Primary Completion: November 1, 2003
• Study Completion: January 1, 2009
• Last Updated: March 18, 2015

Record last verified: 2015-03