A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

NCT ID: NCT01860508

Last Updated: 2013-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Brief Summary

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PFS

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pemetrexed

Group Type EXPERIMENTAL

pemetrexed /carboplatin

Intervention Type DRUG

Interventions

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pemetrexed /carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

.≥65 years or PS 2

* Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
* Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
* Presence of at least one index lesion measurable by CT scan or MRI

* leucocyte ≥ 3.5×109/L
* neutrophil ≥ 1.5×109/L
* platelet ≥ 80×109/L
* Hemoglobin ≥ 9g/L
* ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
* BUN≤ 1.5×ULN
* Signed written informed consent

Exclusion Criteria

* squamous carcinoma or small cell lung cancer
* Patients were allergic to pemetrexed
* Patients received chemotherapy before
* Uncontrolled acute infection

.Uncontrolled pleural effusion
* Severe symptomatic heart disease
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception

* Mental disorientation of disorder
* Glucocorticoids taboo
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Jialei Wang

Attending doctor of medical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jia lei Wang, Master

Role: CONTACT

02164175590 ext. 8907

Facility Contacts

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Jia lei Wang, Master

Role: primary

02164175590 ext. 8907

References

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Zhao X, Yu H, Zhao J, Wu X, Sun S, Luo Z, Wang H, Qiao J, Chang J, Wang J. Efficacy and safety of first-line pemetrexed plus carboplatin followed by single-agent pemetrexed maintenance in elderly Chinese patients with non-squamous non-small-cell lung cancer. Oncotarget. 2017 Sep 23;8(49):86384-86394. doi: 10.18632/oncotarget.21186. eCollection 2017 Oct 17.

Reference Type DERIVED
PMID: 29156802 (View on PubMed)

Other Identifiers

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2013-PEM-WJL

Identifier Type: -

Identifier Source: org_study_id

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