Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer

Eli Lilly and Company1 site in 1 country52 target enrollmentNovember 2002

ConditionsCarcinoma, Non-Small-Cell-Lung Cancer

DrugsGemcitabine cisplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Carcinoma, Non-Small-Cell-Lung Cancer
Sponsor: Eli Lilly and Company
Enrollment: 52
Locations: 1
Primary Endpoint: To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

December 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility 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.

Outcomes

Primary Outcomes

To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer

Secondary Outcomes

To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin
To determine the complete tumor resection rate
To evaluate overall survival and time to documented disease progression