Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung Cancer

Carcinoma, Non Small Cell Lung Clinical Trial

Official title:

A Randomized Phase II Trial of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/ Cisplatin)When Used as Preoperative Chemotherapy for Patients With Stage I and II NSCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191230
• Other study ID #: 5489
• Secondary ID: B9E-US-S236
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: September 2001
• Est. completion date: July 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell lung cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically of cytologically confirmed non small cell lung cancer

• No prior chemotherapy or radiation

• No prior malignancy

Exclusion Criteria:

• Pregnant or breastfeeding

• Serious concomitant systemic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• gemcitabine

• carboplatin

• cisplatin

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pathological response
Secondary	Response rate, disease free survival, toxicity including pulmonary toxicity,operative mortality and quality of life.