Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• define histologic or cytologic diagnosis of non small cell lung cancer.

• determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer.

• define performance status of 0-1 on ECOG scale

• do not have any prior tumor therapy

• to be suitable for curative resection

Exclusion Criteria:

• to have any treatment within the last 30 days with any investigational drug.

• to get concurrent administration of any other tumor therapy

• to be pregnant

• to have poorly controlled diabetes mellitus

• to have serious concomitant disorders.