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

Lilly

Status and phase: Terminated; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: Pemetrexed; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383331

H3E-US-S061

9431

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Pemetrexed

B

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Pemetrexed