NCT00087711 · CITED IN SOURCE DOCUMENTS

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2019-09-12

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: * Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV. * No prior chemotherapy for lung cancer. * Patients must have at least one uni-dimensionally measurable lesion. * Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment. Exclusion Criteria: * Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious cardiac condition. * Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study. * Inability or unwillingness to take folic acid or Vitamin B12 supplementation. * Presence of fluid retention that cannot be controlled by drainage.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: pemetrexed
Drug: cisplatin
label
A
type
EXPERIMENTAL
intervention Names
Drug: gemcitabine
Drug: cisplatin
label
B
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
A
description
500 mg/m2, IV q 21 days x 6 cycles
name
pemetrexed
other Names
LY231514
Alimta
type
DRUG
arm Group Labels
B
description
1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
name
gemcitabine
other Names
LY188011
Gemzar
type
DRUG
arm Group Labels
A
B
description
75 mg/m2, IV, q 21 days x 6 cycles
name
cisplatin
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1713
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Overall survival
time Frame
baseline to date of death from any cause

secondary Outcomes

measure
Progression free survival
time Frame
baseline to measured progressive disease
measure
Time to progressive disease
time Frame
baseline to measured progressive disease
measure
Duration of response
time Frame
time of response to progressive disease
measure
Time to treatment failure
time Frame
baseline to stopping treatment

Full study description

brief Summary: This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Source references

references

citation
Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.
pmid
25082564
type
DERIVED
citation
Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
pmid
22266043
type
DERIVED