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

• Sponsor: Fudan University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01860508
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

PFS

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: pemetrexed /carboplatin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 94 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pemetrexed	Drug: pemetrexed /carboplatin

Outcome Measures

Primary Outcome Measures

1. PFS [from the first cycle of treatment (day one) to two month after the last cycle]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer hospital Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jialei Wang, Attending doctor of medical oncology, Fudan University
• ClinicalTrials.gov Identifier: NCT01860508
• Other Study ID Numbers: 2013-PEM-WJL
• First Posted: May 22, 2013
• Last Update Posted: Jul 8, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Jialei Wang, Attending doctor of medical oncology, Fudan University: Progression free Survival
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carboplatin; Pemetrexed

Study Results

No Results Posted as of Jul 8, 2013