Overview

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

Status:
Completed

Trial end date:
2012-08-01

Target enrollment:
0

Participant gender:
All

Summary

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sun Yat-sen University

Treatments:

BB 1101
Cisplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Folic Acid
Gemcitabine
Hydroxocobalamin
Pemetrexed
Vitamin B 12
Vitamin B Complex
Vitamins

Criteria

Inclusion Criteria:

1. Chemotherapy-naive patients with histologically or cytologically confirmed
adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to
curative treatment or stage IV

2. With at least one unidimensionally measurable lesion according to the Response
Evaluation Criteria in Solid Tumors;

3. with an Eastern CooperativeOncology Group performance status of 0 or 1,

4. At least 18 years of age

5. adequate bone marrow reserve and organ function including calculated creatinine
clearance 45 mL/min based on the standard Cockcroft and Gault formula.

6. Prior radiation therapy was permitted if it was completed at least 4 weeks before
study treatment

7. patients had fully recovered from its acute effects.

Exclusion Criteria:

1. peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1

2. progressive brain metastases,

3. uncontrolled third-space fluid retention before study entry.

4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or
if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.