A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer

Zhejiang Cancer Hospital1 site in 1 country63 target enrollmentJuly 2008

ConditionsNon-Small Cell Lung Cancer

Interventionspemetrexed carboplatin thoracic radiation

Drugspemetrexed carboplatin

Overview

Phase: Phase 2
Intervention: pemetrexed
Conditions: Non-Small Cell Lung Cancer
Sponsor: Zhejiang Cancer Hospital
Enrollment: 63
Locations: 1
Primary Endpoint: tumor response rate
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

July 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
•Presence of measurable disease by RECIST
•Inoperable stage IIIA or IIIB
•ECOG performance status 0-1
•No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
•Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria

•Carcinoid tumor, small cell carcinoma of lung
•Patients with any distant metastasis
•History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
•Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
•Women and men of childbearing potential who have no willing of employing adequate contraception

Arms & Interventions

1

patients receiving pemetrexed, carboplatin and radiation therapy.

Intervention: pemetrexed

1

patients receiving pemetrexed, carboplatin and radiation therapy.

Intervention: carboplatin

1

patients receiving pemetrexed, carboplatin and radiation therapy.

Intervention: thoracic radiation

Outcomes

Primary Outcomes

tumor response rate

Time Frame: Tumor assessments after completion of chemoradiotherapy and every 2 months

Secondary Outcomes

the safety profile(every cycle)
site of first failure in patients who develop progressive disease(baseline to measured progressive disease)
overall survival(baseline to date of death from any cause)
time to progressive disease(baseline to measured progressive disease)