Clinical trial NCT00383331: Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-10-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Best Overall Tumor Response
timeFrame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Secondary outcomes:
measure: Progression Free Survival
timeFrame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
measure: Time to Progressive Disease
timeFrame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
measure: Duration of Response
timeFrame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
measure: Time to Treatment Failure
timeFrame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
measure: Overall Survival
timeFrame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: 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.
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: