Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00383331
• Other study ID #: 9431
• Secondary ID: H3E-US-S061
• Status: Terminated
• Phase: Phase 2
• First received: September 29, 2006
• Last updated: May 28, 2009
• Start date: February 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2009
• 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

This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologic or cytologic diagnosis of NSCLC Stage IIIB or IV

• no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer

• Prior radiotherapy must be completed at least 4 weeks before study enrollment.

Exclusion Criteria:

• estimated life expectancy of 12 weeks

• a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease

• documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment

• significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.

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
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• Pemetrexed
A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles
• Gemcitabine
A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles

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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rochester	Minnesota

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	Best Overall Tumor Response		baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	No
Secondary	Progression Free Survival		baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	No
Secondary	Time to Progressive Disease		baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	No
Secondary	Duration of Response		baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	No
Secondary	Time to Treatment Failure		baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Yes
Secondary	Overall Survival		baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Yes

External Links

•   Lilly Clinical Trial Registry