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

Phase 2

Terminated

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: Pemetrexed; Drug: Gemcitabine

• Registration Number: NCT00383331
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-03
• Study Start: 2007-02
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-06
• Results First Submitted QC: 2009-03-27
• Status Verified: 2009-05
• Results First Posted: 2009-05-14
• Last Update Submitted: 2009-05-28
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Pemetrexed	-
A	Gemcitabine	-
B	Pemetrexed	-
B	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Best Overall Tumor Response	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	baseline to measured progressive disease
Time to Progressive Disease	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Time to progressive disease not analyzed because trial was stopped early due to low enrollment.
Duration of Response	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Duration of response was not analyzed because the trial was stopped early due to low enrollment.
Time to Treatment Failure	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.
Overall Survival	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Survival time is defined as the time from date of randomization to death due to any cause.

Trial Locations

Locations (1)

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, United States